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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

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
Jun 23, 2022 SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 CURAD FIRST AID KIT, SKU 999037 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL... Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT,... Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 GS SALINE SOLUTION 12FL OZ, SKU 902274 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 OPTI FREE REPLENISH MULTI PURPOSE 2 OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 DENTEMP ONE STEP .077OZ, SKU 902139 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 FIRST RESPONSE 2 CT, SKU 902343 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 23, 2022 KY JELLY LUBRICANT 2 FL OZ, SKU 901443 Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... Class II Family Dollar Stores, Llc.
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Randox Cholesterol- For the quantitative in vitro determination of Cholester... Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when cali... Class II Randox Laboratories Ltd.
Jun 22, 2022 CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure mon... Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) ... Class I Integra LifeSciences Corp.
Jun 22, 2022 Revogene, Catalog no. 610210. IVD test instrument When a run is aborted, the cooling period protection does not occur and the user is able to open ... Class II Meridian Bioscience Inc
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in.... The product falls apart during handling after removal from its primary packaging. Class II ASO LLC
Jun 22, 2022 ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: ... There is a potential risk of medication error when using specific Abacus Order Entry & Calculatio... Class I Baxter Healthcare Corporation
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) de... Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar e... Class II Intuitive Surgical, Inc.
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2022 AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended ... Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic comp... Class II Fresenius Medical Care Holdings, Inc.
Jun 21, 2022 etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. Device was marketed without FDA 510(k) clearance or a PMA. Class II Touch US Llc
Jun 21, 2022 AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended... Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic comp... Class II Fresenius Medical Care Holdings, Inc.
Jun 20, 2022 Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle ... BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from in... Class I Bard Access Systems, Inc.
Jun 20, 2022 Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, H... Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Tra... Class II NuVasive Inc
Jun 17, 2022 Verigene CDF Nucleic Acid Test, Part No. 30-002-22 There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... Class II Luminex Corporation
Jun 17, 2022 Merlin.net model MN5000 Software The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022 VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... Class II Luminex Corporation
Jun 17, 2022 Merlin PCS 3650 programmer Model 3330 software There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022 Merlin 2 PCS MER37000 programmer Model MER3400 software The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 16, 2022 Various PICC Line, Central Line Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Laparoscopy Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various hysterectomy, vaginal packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Cysto Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Angiography/Cath Lab packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various ENT Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic P... Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... Class II Fresenius Medical Care Holdings, Inc.
Jun 16, 2022 Various Pacemaker Packs, Cardio Thoracic Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various neurology packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various eye packs, cataract packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 nordicBrainEX, software versions 2.21 through 2.3.10 When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both th... Class II NordicNeuroLab AS
Jun 16, 2022 Various ob/gyn packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Port Insertion Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 D&C pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.

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.