Learn from the record. Every FDA recall is a quality signal.

Kits contain a potentially contaminated component which were recalled by the manufacturer

The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Subpotent Drug

Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list

Component labeling discrepancy

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Foreign object: products may contain glass pieces

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Subpotent Drug

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Subpotent Drug

Kits contain a potentially contaminated component which were recalled by the manufacturer

Product had a presumptive positive test result for Listeria monocytogenes

Subpotent Drug

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Subpotent Drug

Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.

Presence of Particulate matter.

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Label does not declare walnuts in English

Label does not declare walnuts in English

Undeclared peanuts.

Failed content uniformity specifications.

Subpotent Drug

Kits contain a potentially contaminated component which were recalled by the manufacturer

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

Software issue may cause the ruler measurement to be inaccurate.

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Potential Salmonella Javiana contamination

Kits contain a potentially contaminated component which were recalled by the manufacturer

Test manufactured with an expired ingredient which may present as either a false negative or positive.

Kits contain a potentially contaminated component which were recalled by the manufacturer

Foreign object: products may contain glass pieces

The product contains 1,4-DMAA, Phenylethylamine and Phenibut.

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

Subpotent Drug

Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.

Foreign object: products may contain glass pieces

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Subpotent Drug

Test manufactured with an expired ingredient which may present as either a false negative or positive.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

Foreign object: products may contain glass pieces

Undeclared peanuts.

Product may be contaminated with Salmonella.

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Product may have been improperly pasteurized.

Foreign object: products may contain glass pieces

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Kits contain a potentially contaminated component which were recalled by the manufacturer

Presence of particulate matter: glass and stopper piece

Kits contain a potentially contaminated component which were recalled by the manufacturer

Label does not declare walnuts in English

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Kits contain a potentially contaminated component which were recalled by the manufacturer

Subpotent Drug

Kits contain a potentially contaminated component which were recalled by the manufacturer

Subpotent Drug

The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).

Subpotent Drug

Foreign object: products may contain glass pieces

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Kits contain a potentially contaminated component which were recalled by the manufacturer

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Potential of failing to trigger clinical scan during Bolus Tracking.

Kits contain a potentially contaminated component which were recalled by the manufacturer

Software issue may cause measurements to be displayed inaccurately.

Subpotent Drug

Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

Undeclared Egg Allergen

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Due to potential E. coli O145:H28 contamination

Lack of Assurance of Sterility

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Potential foreign object contamination: rubber pieces

Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

Due to potential E. coli O145:H28 contamination

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Devices could potentially be occluded or partially occluded.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

Potential Salmonella contamination

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Device will intermittently provide inaccurate data related to native heart rate.

Potential for arterial sheath tip separation or partial tip separation during use.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

Device will intermittently provide inaccurate data related to native heart rate.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Software issue that can cause an increase in spontaneous software closures.

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Overheating of the 115V CPU board may cause the device to shut down.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

Urostomy Pouches may leak from cap during use.

Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Overheating of the 115V CPU board may cause the device to shut down.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Salmonella. The firm received a positive test result of Salmonella in the product.

After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

Potential Salmonella Javiana contamination

Potential for electrical discharge from unit when unplugged.

Jalapenos may be contaminated with Salmonella.

CGMP deviations: tablets with black specks.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Potential for arterial sheath tip separation or partial tip separation during use.

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Overheating of the 115V CPU board may cause the device to shut down.

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

Due to potential E. coli O145:H28 contamination

Inaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated).

Foreign object: May contain metal pieces

Inaccurately declared nutrients including Potassium (overstated), Calcium (overstated), and Iron (understated).

Failed Dissolution Specifications

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Due to potential E. coli O145:H28 contamination

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Soy not declared in the contains statement.

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated).

The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.

Devices could potentially be occluded or partially occluded.

The module did not undergo electrical safety tests and functional tests during production.

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

Inaccurately declared nutrients including Iron (understated), and Vitamin D (overstated).

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Due to an increase rate of balloon pinhole defects.

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Potential Cyclospora contamination.

Potential Cyclospora contamination.

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Potential Cyclospora contamination.

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Possible Salmonella Enteritidis

Potential Cyclospora contamination.

Potential Cyclospora contamination.

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

Due to increase in false negative results

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Lack of assurance of sterility. The recall is due to potential contamination

Potential Cyclospora contamination.

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Potential Cyclospora contamination.

Due to off-the-shelf display port component that has audio/video failures

Potential Cyclospora contamination.

Potential Cyclospora contamination.

Undeclared peanuts

CGMP Deviations:Noted during FDA inspection

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Potential Cyclospora contamination.

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

CGMP Deviations:Noted during FDA inspection

Failed Dissolution Specifications

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Potential Cyclospora contamination.

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Undeclared Red #40.

Undeclared Egg

Label declares cream and cheese, but Milk is not declared

Presence of Particulate Matter

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Presence of Particulate Matter

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Possible Salmonella Enteritidis

Potential Cyclospora contamination.

Potential Cyclospora contamination.

Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

Potential Cyclospora contamination.

Potential Cyclospora contamination.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Potential Cyclospora contamination.

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Potential Cyclospora contamination.

Potential Cyclospora contamination.

Firmware issue potentially leading to loss of geometry movements.

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Products may not have received adequate sterilization processing.

CGMP Deviations:Noted during FDA inspection

CGMP Deviations:Noted during FDA inspection

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

CGMP Deviations:Noted during FDA inspection

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Potential Cyclospora contamination.

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Potential Cyclospora contamination.

The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Potential Cyclospora contamination.

Potential Cyclospora contamination.

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

Possible Cyclospora Contamination

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Potential for breach in sterile barrier of device packaging.

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Potential for breach in sterile barrier of device packaging.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Product contaminated with Listeria monocytogenes.

This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.

Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Undeclared allergen (egg)

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Product contaminated with Listeria monocytogenes.

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Product contaminated with Listeria monocytogenes.

Possible foreign object (thin, soft plastic strands).

Product contaminated with Listeria monocytogenes.

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

shortfill; reports of empty capsules.

Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.