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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 4, 2020 ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI N... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline... There is a potential for the product to exhibit holes in the packaging, which impacts package int... Class II Resource Optimization & Innovation LLC
May 4, 2020 Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number ... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: Thes... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 4, 2020 Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UD... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated fo... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 4, 2020 Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Fl... There is a potential for the product to exhibit holes in the packaging, which impacts package int... Class II Resource Optimization & Innovation LLC
May 4, 2020 Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Num... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are ... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 4, 2020 AC Powered hospital adjustable bed. Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall. Class II Umano Medical, Inc.
May 4, 2020 ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 BioFlo Midline Convenience Kits - Product Usage: These introducers are used f... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 1, 2020 Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Produ... Device and tray that houses the device did not pass steam sterilization process validation testing Class II Biomet
May 1, 2020 Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 Device and tray that houses the device did not pass steam sterilization process validation testing Class II Biomet
Apr 30, 2020 Pressure Monitoring Tray, C-PMSY, G02854 The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or in... Class II Cook Inc.
Apr 30, 2020 MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K... Missing solder battery connection, which could interrupt power of insulin pump. Class II Medtronic Inc.
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 40... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL F... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx On... Missing solder battery connection, which could interrupt power of insulin pump. Class II Medtronic Inc.
Apr 30, 2020 Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Produ... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code:... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Centrella Smart+ Bed, Catalog Number P7900 The Bed Exit System may fail to send a remote alert through the nurse call system if a remote ale... Class II Hill-Rom, Inc.
Apr 30, 2020 MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK... Missing solder battery connection, which could interrupt power of insulin pump. Class II Medtronic Inc.
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Se... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS Incorrect labeling of dialysate concentration for hemodialysis. Class II Diasol, Inc
Apr 30, 2020 Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm)... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm),... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-... Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lea... Class II Siemens Medical Solutions USA, Inc
Apr 30, 2020 Pressure Monitoring Set, C-PMS, G02838 The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or in... Class II Cook Inc.
Apr 30, 2020 Remisol Advance running Software Version 1.12 The Normand Info Remisol Adv... Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and ... Class II Normand-Info S.A.S.U.
Apr 30, 2020 Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Pro... potential risk that Legionella may be present in the Unity machine room, specifically the heat ex... Class II Elekta, Inc.
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Se... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.