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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
Apr 2, 2026 Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Apr 2, 2026 Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Apr 2, 2026 Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Mar 30, 2026 Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl a... Ten complaints have been received identifying issues at the time of use related to the package se... Class II Zimmer, Inc.
Mar 5, 2026 COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Jan 20, 2026 cobas pro integrated solutions with cobas c 503 analytical units: cobas pr... Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spl... Class II Roche Diagnostics Operations, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Dec 2, 2025 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... Affected implants may have undersized distal diameter along length of the shaft, which could lead... Class II Zimmer, Inc.
Nov 26, 2025 Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 26, 2025 R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 26, 2025 Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 21, 2025 The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay wit... Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. ... Class II Roche Diagnostics Operations, Inc.
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 23, 2025 BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Numbe... There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint... Class II Biomet, Inc.
Sep 18, 2025 Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... Affected devices may contain PTFE coating scrapings. Scrapings could be released during device de... Class I Cook Medical Incorporated
Sep 9, 2025 Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi... Class II Biomet, Inc.
May 15, 2025 Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... Cook Medical identified that catheters supplied in the affected device lots may experience tip se... Class I Cook 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.