[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
1,158 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-04-29 | Class II | Medline Industries, LPZ-1844-2026 | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Documentation & Change Control |
| 2026-04-29 | Class II | Medline Industries, LPZ-1881-2026 | Unapproved design changes to the products outside of the 510(k) clearance. | Documentation & Change Control |
| 2026-04-29 | Class II | Olympus Corporation of the AmericasZ-1909-2026 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Risk Management & CAPA |
| 2026-04-29 | Class II | Medline Industries, LPZ-1834-2026 | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Documentation & Change Control |
| 2026-04-29 | Class II | Windstone Medical Packaging, Inc.Z-1920-2026 | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion). | — |
| 2026-04-22 | Class I | B Braun Medical IncZ-1800-2026 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | — |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1819-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Linkbio Corp.Z-1810-2026 | The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. | Documentation & Change Control |
| 2026-04-22 | Class I | B Braun Medical IncZ-1803-2026 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | — |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1817-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1818-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class I | B Braun Medical IncZ-1802-2026 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | — |
| 2026-04-22 | Class I | B Braun Medical IncZ-1799-2026 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | — |
| 2026-04-22 | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o.Z-1811-2026 | An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm. | — |
| 2026-04-22 | Class II | 3B Medical, Inc.Z-1815-2026 | Devices which did not meet internal quality specifications were inadvertently distributed. | Validation & Qualification |
| 2026-04-22 | Class I | Insulet CorporationZ-1797-2026 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the de | Environmental Monitoring |
| 2026-04-22 | Class II | Remel, IncZ-1806-2026 | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. | Environmental Monitoring |
| 2026-04-22 | Class II | Gentuity, LLCZ-1823-2026 | The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging. | Data Integrity |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1820-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Wilson-Cook Medical Inc.Z-1812-2026 | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. | Risk Management & CAPA |
| 2026-04-22 | Class II | THERAKOS DEVELOPMENT LIMITEDZ-1822-2026 | Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss. | — |
| 2026-04-22 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1805-2026 | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions. | — |
| 2026-04-22 | Class II | Beta Bionics, Inc.Z-1809-2026 | it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery. | — |
| 2026-04-22 | Class II | Clariance-SASZ-1821-2026 | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | — |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1816-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.