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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
May 12, 2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, L... Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... Class II W L Gore & Associates, Inc.
May 12, 2021 Symmetry Plus Treatment Recliner - general hospital use as a convenient seati... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 ComfortGel - assists in the prevention and treatment of all pressure injury s... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Stretcher Chair-for use in all acute care hospitals and medical outpatient se... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 CUB Pediatric Crib- intended to provide a pediatric patient support surface f... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Transport Stretcher 747 - a non-powered, wheeled device designed to support p... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 S3 MedSurg Bed - intended to support and transport patients within the Med/Su... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: ... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 InTouch 2131-intended to support a human patient in an acute care setting, M... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, L... Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... Class II W L Gore & Associates, Inc.
May 12, 2021 Michael Graves with Stryker Highback Chair-intended for pediatric and adult p... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 S3 MedSurg Bed - intended to support and transport patients within the Med/Su... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 Proform- support surface is used to assist in the prevention and treatment of... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 12, 2021 CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)0086... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and sh... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 7, 2021 Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 ... Mislabeled product labeling references incorrect length or height, or length and height for speci... Class II K2M, Inc
May 7, 2021 Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 ... Mislabeled product labeling references incorrect length or height, or length and height for speci... Class II K2M, Inc
May 7, 2021 Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 ... Mislabeled product labeling references incorrect length or height, or length and height for speci... Class II K2M, Inc
May 6, 2021 Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS,... Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... Class II Corin Ltd
May 6, 2021 Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hi... Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... Class II Corin Ltd
Apr 30, 2021 CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Dispo... The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a pa... Class II CooperSurgical, Inc.
Apr 26, 2021 REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 21, 2021 VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ... The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. Class II Anodyne Surgical
Apr 21, 2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 20, 2021 Logical cup liner - Product Usage: intended to replace a hip joint where bone... Product mislabeled, with the incorrect product inside the package. Class II Signature Orthopedics Pty Limited
Apr 14, 2021 Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrec... Barcode label extended expiration date. Barcode located at the short side of the outer box shows ... Class II Dutch Ophthalmic USA, Inc.
Apr 9, 2021 PERLA TL Lateral Connector Open - Product Usage: intended to be used with aut... Due to external labelling error/mix-up. Affected product external labels list the incorrect rod ... Class II SPINEART SA
Apr 8, 2021 Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR ... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 8, 2021 CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw Class II Smith & Nephew, Inc.
Apr 8, 2021 Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bo... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 5, 2021 GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliar... The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endopros... Class II W.L. Gore & Associates, Inc.
Apr 1, 2021 Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF:... single use devices labeled as sterile may not have been adequately sterilized Class II CLINICAL LASERTHERMIA SYSTEMS AB
Apr 1, 2021 Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used ... single use devices labeled as sterile may not have been adequately sterilized Class II CLINICAL LASERTHERMIA SYSTEMS AB
Apr 1, 2021 Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Pro... single use devices labeled as sterile may not have been adequately sterilized Class II CLINICAL LASERTHERMIA SYSTEMS AB
Mar 31, 2021 Palm Cups - Product Usage: intended to be used to percuss the chest wall to m... The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... Class II Smiths Medical ASD Inc.
Mar 31, 2021 ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the d... The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... Class II Smiths Medical ASD Inc.
Mar 31, 2021 AM12M Acquisition Module accessory. Impacted software version of the AM12M i... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module acces... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 26, 2021 INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibia... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation

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.