[ 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 |
|---|---|---|---|---|
| 2026-07-08 | Class II | Medline Industries, LPZ-2540-2026 | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Risk Management & CAPA |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2659-2026 | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Risk Management & CAPA |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2664-2026 | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Risk Management & CAPA |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2663-2026 | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Risk Management & CAPA |
| 2026-07-08 | Class II | Zimmer Surgical IncZ-2673-2026 | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. | Environmental Monitoring |
| 2026-07-08 | Class I | Windstone Medical Packaging, Inc.Z-2622-2026 | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Environmental Monitoring |
| 2026-07-08 | Class II | Baxter Healthcare CorporationZ-2638-2026 | The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables. | — |
| 2026-07-08 | Class II | Boston Scientific CorporationZ-2628-2026 | Potential sterile breach of the pouches in which devices are packaged. | Environmental Monitoring |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2568-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Ventec Life Systems, Inc.Z-2525-2026 | Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition. | — |
| 2026-07-01 | Class II | Philips North America LlcZ-2522-2026 | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | Documentation & Change Control |
| 2026-07-01 | Class II | Dexcom, Inc.Z-2574-2026 | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk. | Environmental Monitoring |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2558-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2572-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Zimmer, Inc.Z-2578-2026 | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | Documentation & Change Control |
| 2026-07-01 | Class II | Medline Industries, LPZ-2590-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Medline Industries, LPZ-2582-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Boston Scientific CorporationZ-2580-2026 | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. | — |
| 2026-07-01 | Class II | Intuitive Surgical, Inc.Z-2521-2026 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding. | — |
| 2026-07-01 | Class II | Medline Industries, LPZ-2591-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Stryker NeurovascularZ-2552-2026 | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. | — |
| 2026-07-01 | Class II | Medtronic Perfusion SystemsZ-2577-2026 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Documentation & Change Control |
| 2026-07-01 | Class I | Abiomed, Inc.Z-2600-2026 | Potential for thrombus formation during prolonged use of the introducer. | — |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2565-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Medtronic Perfusion SystemsZ-2576-2026 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Documentation & Change Control |
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.