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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

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Dec 14, 2018 COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant A... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and... Class II Roche Diagnostics Corporation
Nov 28, 2018 Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 P... There is a potential for silicone shedding during cleaning and sterilization. Class II Zimmer Biomet, Inc.
Nov 28, 2018 Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 ... There is a potential for silicone shedding during cleaning and sterilization. Class II Zimmer Biomet, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 14, 2018 Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT... Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. Class II Zimmer Biomet, Inc.
Oct 31, 2018 NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size ... Screw is missing from the package Class II Zimmer Biomet, Inc.
Oct 24, 2018 Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inser... Potential metal burrs in the holes of the device preventing the appropriate drill and transverse... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Di... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Num... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diam... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item N... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm ... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 12, 2018 Zimmer Compress Devices and Instruments: Item Number/Item Description 17835... Correction to update the surgical technique for the Compress System. To make users aware of the c... Class II Zimmer Biomet, Inc.
Oct 10, 2018 Comprehensive Mini Stem, Item No. 113631: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... Class II Zimmer Biomet, Inc.
Oct 10, 2018 Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 Th... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 Th... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Sep 25, 2018 Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 P... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Pro... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated

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.