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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

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

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DateProductReasonClassFirm
Mar 23, 2021 Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 16, 2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... Incorrect size printed on the device; packaging is labeled correctly. Class II Medtronic Inc.
Mar 5, 2021 MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Mar 5, 2021 Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in ske... Centinel Spine learned through five customer complaints that the product was missing the "UP" etc... Class II Centinel Spine, Inc.
Mar 5, 2021 Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re... The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L... Class II Howmedica Osteonics Corp.
Mar 5, 2021 MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Feb 26, 2021 Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 1, 2021 HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutt... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for c... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 19, 2021 Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates that the device is fo... Class II Covidien Llc
Jan 11, 2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, uro... The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. Class II C.R. Bard, Inc.
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which could impact the seal ... Class II Ethicon, Inc.
Dec 23, 2020 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... Class II Becton Dickinson & Company
Nov 25, 2020 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II 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.