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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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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Jul 6, 2023 Medtronic InterStim Ground Pad REF 041826 Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... Class II Medtronic Neuromodulation
Jun 28, 2023 The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be us... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone ... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II Medtronic Neurosurgery
Jun 28, 2023 stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone c... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 22, 2023 Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access Three lots of product may be labeled with an incorrect expiration day Class II Creganna Medical Devices
Jun 16, 2023 CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO 30mm screws were labeled as 25mm screws. Class II Conformis, Inc.
Jun 14, 2023 Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A... There is a potential for the direct amplification disc to malfunction which may result in spilla... Class II DiaSorin Molecular LLC
Jun 12, 2023 AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... Class II Tornier, Inc
Jun 12, 2023 AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... Class II Tornier, Inc
May 30, 2023 Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION W... The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDAR... The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF... The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK,... The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Alinity ci-series System Control Module, REF: 03R70-01 There are potential performance issues found in the Alinity ci-series System software versions 3.... Class II Abbott Laboratories
May 26, 2023 Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disi... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway managemen... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level di... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level dis... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 24, 2023 NeuMoDx Cartridge-used for extraction, purification, amplification and detect... Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied d... Class II NeuMoDx Molecular Inc
May 19, 2023 Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-9... GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h... Class II DATEX--OHMEDA, INC.
May 19, 2023 Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 20... GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h... Class II DATEX--OHMEDA, INC.
May 19, 2023 NexGen Precoat Stemmed Tibial Plate Size 5 Device outer packaging was incorrectly labeled. Class II Zimmer, Inc.
May 18, 2023 MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLAST... Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOIN... Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield

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.