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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Nov 3, 2023 STERILE STERILE PREP STICK, REF DYNDA1134 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP, REF DYNDA1649 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE BETADINE, REF DYNDA1998 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE POVIDONE, REF DYNDA2061 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP SOLUTION, REF DYNDA1907 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 Atrium Oasis Drain Single W / AC, Part No. 3600-100 A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expira... Class II Atrium Medical Corporation
Oct 27, 2023 PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 Due to incorrect product labeling Class II Limacorporate S.p.A
Oct 23, 2023 stryker Sage PrimaFit External Urine Management System for the Female Anatomy A small percentage of devices in three lots of product may contain a tape with a natural rubber l... Class II Sage Products Inc
Oct 19, 2023 ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 16, 2023 Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality ... Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws ... Class II Zimmer Biomet Spine Inc.
Oct 13, 2023 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not bei... Class II Avanos Medical, Inc.
Oct 13, 2023 Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revisi... Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... Class II Corin Ltd
Oct 13, 2023 Unity Total Knee System, Model Number 112.001.34. Primary and revision t... Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... Class II Corin Ltd
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 11, 2023 BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILT... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 10, 2023 Stay Safe Cap Updating the labeling to include additional warnings and contraindications for potential side eff... Class II Fresenius Medical Care Holdings, Inc.
Oct 9, 2023 MED-810A Zemits NDPrime Laser products Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product ... Class II Advance-Esthetic LLC
Oct 5, 2023 REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Mislabeling Class II Encore Medical, LP
Oct 5, 2023 Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32... Mislabeling Class II Encore Medical, LP
Oct 4, 2023 VERIQUICK PREGNANCY TEST 1CT, SKU 901260 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Integris-Allura IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Azurion IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 ORAL B MOUTH SORE RINSE 237ML, SKU 999087 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU ... Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 AT HOME MARIJUANA TEST STRIP, SKU 900752 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Zenition 50 & 70 Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN ... Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Veradius Unity Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 FIRST RESPONSE 2 CT, SKU 902343 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 Allura Xper IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 DENTEMP ONE STEP .077OZ, SKU 902139 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 4, 2023 MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 Products were stored outside of labeled temperature requirements. Class II Family Dollar Stores, Llc.
Oct 2, 2023 Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL... Due to product outer packaging incorrectly labeled. Class II Edge Biologicals Inc
Oct 2, 2023 ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy... Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. Class II Olympus Corporation of the Americas
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... Class II Instrumentation Laboratory
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... Class II Instrumentation Laboratory
Sep 29, 2023 Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled e... Class II Atrium Medical Corporation
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... Class II Instrumentation Laboratory
Sep 27, 2023 JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... Class II Smith & Nephew, Inc.
Sep 27, 2023 JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... Class II Smith & Nephew, 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.