Device recalls
Device recalls with the root cause, the firm, the products and the recall status. 59,705 records; openFDA updated it 2026-11-13. About this dataset
Newest records
- Other8,928
- Device Design7,678
- Under Investigation by firm7,031
- Process control6,625
- Nonconforming Material/Component5,990
- Software design3,532
- Packaging1,667
- Component design/selection1,611
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN387V (HSI Item No. 600-9683); Pro…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8695P (HSI Item No.…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (…FDA page
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · The mounting bolts securing the C-arm drive unit of the X-ray system may not be torqued to specification, potentially compromising structural stability and saf…
- Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer L…FDA page
restor3d Inc. · (Retroactively reported) Pairing of shoulder implant stem sizes 1 and 2 with the largest glenosphere diameter (40 mm) creates an excessive mechanical loading c…
- Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000 UDI-DI codes: 9321502069847 Cochlea…FDA page
Cochlear Limited · Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits
- TruSystem 7500 surgical table, Model/Catalog Number: 4091000FDA page
Baxter Healthcare Corporation · There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, th…
- Operating table column TS7500 MOBIUS, Hybrid operating table column, Model/Catalog Number: 1704695FDA page
Baxter Healthcare Corporation · There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, th…
- Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788FDA page
Baxter Healthcare Corporation · There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, th…
- Operating Table TruSystem 7000 U (dV), Model/Catalog Number: 1723633FDA page
Baxter Healthcare Corporation · There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, th…
- TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087FDA page
Baxter Healthcare Corporation · There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, th…
- Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimensFDA page
Remel, Inc · Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.
- Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.FDA page
CORIN MEDICAL, LTD. · Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be…
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) STR…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT, C…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) IV…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN G…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.