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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

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DateProductReasonClassFirm
Feb 13, 2015 - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio ... The firm is recalling sterile enteral feeding syringes due to determining that the sterility of t... Class II Medela Inc. EF Division
Feb 12, 2015 Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouche... Devices were not sterilized Class II Ameda, Inc.
Feb 12, 2015 Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primar... Devices were not sterilized Class II Ameda, Inc.
Feb 11, 2015 Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... Class II Sybron Dental Specialties
Feb 9, 2015 CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 Incorrect size printed on the Milex Pessary Kit packaging label Class II CooperSurgical, Inc.
Jan 30, 2015 Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard E... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jan 22, 2015 GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered ... The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex... Class II Zimmer Dental Inc
Jan 15, 2015 ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packagin... On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering... Class II Advanced Medical Solutions Ltd.
Jan 15, 2015 ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary pa... On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discoverin... Class II Advanced Medical Solutions Ltd.
Jan 14, 2015 Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla... Potential for failure of the pouch packaging seal at high altitudes. Class II Baxter Healthcare Corp.
Jan 9, 2015 Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 9, 2015 Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis co... Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 9, 2015 Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only,... Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; T... Class II Teleflex Medical
Jan 8, 2015 Pilling Modular Verres Body/Obturator, Product Code 140880 Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a... Class II Teleflex Medical
Jan 7, 2015 Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Ada... The taper adaptor is missing from the packaging, which may result in a delay in surgery greater t... Class II Biomet, Inc.
Dec 4, 2014 DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone vo... The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above ma... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 4, 2014 Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... There is the potential for a breach in the inner or outer packaging pouches of all lots of the Im... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Dec 4, 2014 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... There is the potential for a breach in the inner or outer packaging pouches of all lots of the St... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Dec 2, 2014 Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identi... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Dec 2, 2014 Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Nam... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Nov 21, 2014 Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... Affected product may have compromised sterility due to packaging defects. It was determined that ... Class II Atricure Inc
Nov 6, 2014 Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate... AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.... Class II Abbott Medical Optics Inc (AMO)
Nov 5, 2014 Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ ... Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Di... Class II Gambro Renal Products Inc
Nov 5, 2014 Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revacle... Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Di... Class II Gambro Renal Products Inc
Nov 4, 2014 STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor... Internal testing and investigation of the packaging revealed cracks and holes in primary packaging Class II Pulsion Medical Inc
Nov 4, 2014 STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD S... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Oct 31, 2014 The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bi... Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenat... Class II Medtronic Perfusion Systems
Oct 31, 2014 UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary p... Packaging non-conformance related to the integrity of the sterile pouch seal. Class II US Endoscopy Group Inc
Oct 21, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile... Class II Gyrus Acmi, Incorporated
Oct 15, 2014 AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS M... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 15, 2014 AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 14, 2014 St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Mo... St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Re... Class II St Jude Medical
Oct 13, 2014 Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot ... Class II Medtronic Vascular
Oct 8, 2014 Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Extremity PACK, catalog #900-2615 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, 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.