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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

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
Sep 25, 2018 Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 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 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 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 80mm, Catalog Number: ZIB6-80-5.0-80 Prod... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 25, 2018 Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 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 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 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 80mm, Catalog Number: ZIB6-125-5.0-80 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 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Produ... 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 20mm, Catalog Number: ZIB6-125-5.0-20 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 40mm, Catalog Number: ZIB5-125-4.0-40 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 30mm, Catalog Number: ZIB6-80-12.0-30 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 80mm, Catalog Number: ZIB6-80-12.0-80 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 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 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 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 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 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 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 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 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 30mm, Catalog Number: ZIB6-125-5.0-30 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 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 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 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 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 80mm, Catalog Number: ZIB6-125-14.0-80 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 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 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 30mm, Catalog Number: ZIB6-80-5.0-30 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 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 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 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Pr... The instruction for use detail, with respect to removal of the delivery system as part of Deploym... Class II Cook Medical Incorporated
Sep 24, 2018 Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Pro... Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 u... Class II Roche Diagnostics Corporation
Sep 21, 2018 CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage:... There is the potential for debris/material to be found behind the O-rings in the neck trials. Class II DePuy Orthopaedics, Inc.
Sep 21, 2018 CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: T... There is the potential for debris/material to be found behind the O-rings in the neck trials. Class II DePuy Orthopaedics, Inc.
Sep 21, 2018 CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Us... There is the potential for debris/material to be found behind the O-rings in the neck trials. Class II DePuy Orthopaedics, Inc.
Sep 21, 2018 StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-us... There is a potential for comingling of the 43MM and 51 MM molds Class II Zimmer Biomet, Inc.
Sep 13, 2018 CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips... Abnormally high INR test results with the affected CoaguChek test strips Class I Roche Diagnostics Corporation
Aug 22, 2018 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref N... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Numbe... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pac... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pac... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref N... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pa... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Prod... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, 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.