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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
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For u... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 ... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 3, 2017 Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage:... The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on... Class II OrthoPediatrics Corp
Aug 1, 2017 Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a... The products being recalled exceeded the weight previously tested leading to a possibility of dam... Class II Zimmer Biomet, Inc.
Aug 1, 2017 Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT... The products being recalled exceeded the weight previously tested leading to a possibility of dam... Class II Zimmer Biomet, Inc.
Jul 31, 2017 Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregn... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 28, 2017 Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 0564... A software failure may incorrectly set the system settings to "default" settings, creating a risk... Class II Roche Diagnostics Corporation
Jul 18, 2017 cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 ... A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series ... Class II Roche Diagnostics Corporation
Jul 18, 2017 cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 ... A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODU... Class II Roche Diagnostics Corporation
Jul 14, 2017 PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 The lift motor used to raise and lower the overhead chassis will wear if not properly maintained ... Class II Panoramic Rental Corp.
Jul 12, 2017 CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... Class II DePuy Orthopaedics, Inc.
Jul 12, 2017 CORAIL HIGH OFFSET STEM Collarless SIZE 14 Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... Class II DePuy Orthopaedics, Inc.
Jul 5, 2017 Persona Partial Knee System, Size 8, Finishing Guide Finishing guide does not adequately account for shape differences present in Size 8 of Persona Pa... Class II Zimmer Biomet, Inc.
Jul 5, 2017 Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/P... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... Class II Roche Diagnostics Corporation
Jul 5, 2017 cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... Class II Roche Diagnostics Corporation
Jun 30, 2017 DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty Product may contain the presence of melted sterile packaging upon opening. Class II Zimmer Biomet, Inc.
Jun 30, 2017 JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty For soft tissue fixation Class II Zimmer Biomet, Inc.
Jun 29, 2017 Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MOD... Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 17... Class II Roche Diagnostics Corporation
Jun 29, 2017 PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plas... Device was distributed with the etching missing from the product. Class II Zimmer Biomet, Inc.
Jun 16, 2017 ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem ... Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with S... 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.