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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

Infrastructure

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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 25, 2016 Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8... Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w... Class III GSK Consumer Healthcare
Apr 18, 2016 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Prod... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 18, 2016 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product U... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 15, 2016 VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu... Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. Class III Biomerieux France Chemin De L'Or
Apr 14, 2016 Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: ... BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... Class II B. Braun Medical, Inc.
Apr 14, 2016 Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve ... BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... Class II B. Braun Medical, Inc.
Apr 12, 2016 Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 4, 2016 Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripher... Device packaging may not be sealed. Class II Stryker Sustainability Solutions
Apr 4, 2016 Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 Device packaging may not be sealed. Class II Stryker Sustainability Solutions
Apr 1, 2016 Various trauma and sports medicine instruments and implants. guide, surgical... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Bit, drill. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Passer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Pin, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Appliance, fixa... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Fastener, fixat... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Plate, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Reamer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. cannula, surgic... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Orthopedic manu... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Arthroscope. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Screw, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Spinal interlam... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Rod, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Mar 31, 2016 Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgi... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) P... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company

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.