Browse Device Recalls

950 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 950 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 950 FDA device recalls in MI.

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Date	Product	Reason	Class	Firm
Oct 23, 2017	NEONATAL IV ACCESS SET	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 16, 2017	The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re...	Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 21, 2017	MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-P...	It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity...	Class II	Stryker Medical Division of Stryker Corporation
Jul 5, 2017	SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold...	Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manu...	Class II	Centurion Medical Products Corporation
Jul 5, 2017	Phadia 1000 Instrument, Article Number 12-3800-01.	The "Retry" command does not function properly which could cause a shortage of Wash and Rinse sol...	Class II	Phadia US Inc
Mar 29, 2017	Medi-Therm Hyper/Hypothermia System, MTA7900	The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to...	Class II	Stryker Medical Division of Stryker Corporation
Mar 15, 2017	Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome...	Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.	Class II	Richard-Allan Scientific Company
Mar 10, 2017	Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a ...	Product shipped proximate to or past the expiration date listed on the product label.	Class II	Stryker Instruments Div. of Stryker Corporation
Mar 9, 2017	OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individuall...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Mar 9, 2017	EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and st...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Mar 9, 2017	POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads ...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Mar 9, 2017	POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packag...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Mar 9, 2017	OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually pac...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Mar 9, 2017	OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually ...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Mar 9, 2017	CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packag...	Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa...	Class II	Centurion Medical Products Corporation
Feb 28, 2017	Stryker SmartLife Large Aseptic Housing (7126-120-000)	Stryker Instruments issued a notice of correction for an update to cleaning practices for the Str...	Class II	Stryker Instruments Div. of Stryker Corporation
Feb 20, 2017	Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: ...	Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du...	Class II	Terumo Cardiovascular Systems Corporation
Feb 20, 2017	Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090	Potential for poly tip of the mallet to come off during use. Potential for foreign material in t...	Class II	Signal Medical Corporation
Feb 20, 2017	Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage:...	Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du...	Class II	Terumo Cardiovascular Systems Corporation
Jan 30, 2017	EliA Sample Diluent, Article number, 83-1023-01	Erroneous EliA test results related to problems with liquid level detection and diluent pipetting...	Class II	Phadia US Inc
Jan 20, 2017	CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is Cav...	Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the ...	Class II	Metrex Research, LLC.
Nov 30, 2016	8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MI...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016	8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryk...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016	8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MI...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016	8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minim...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016	8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MI...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016	8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryk...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 30, 2016	8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MI...	Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because ...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 8, 2016	Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled	Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to com...	Class II	Stryker Medical Division of Stryker Corporation
Oct 21, 2016	Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Mul...	The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to r...	Class I	Centurion Medical Products Corporation
Oct 11, 2016	RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U	Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged ...	Class III	Stryker Instruments Div. of Stryker Corporation
Sep 25, 2016	Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the di...	Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe...	Class III	Acumedia Manufacturers, Inc.
Sep 16, 2016	RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm...	RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ ...	Class II	RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Sep 9, 2016	Zero-Gravity Radiation Protection System Radiology Personnel protective shi...	Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise...	Class II	Contour Fabricators Inc
Aug 25, 2016	United Nuclear Scientific High Power Handheld Lasers. Laser products	Failure to comply with the laser class limitation listed in the performance standard for Specific...	Class II	United Nuclear Scientific Supplies, LLC
Aug 17, 2016	Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: ...	Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potentia...	Class II	Stryker Instruments Div. of Stryker Corporation
Aug 8, 2016	Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Produc...	Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe...	Class III	Acumedia Manufacturers, Inc.
Jul 20, 2016	Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOS...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in ...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in ...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOS...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITR...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the qu...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in th...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 20, 2016	Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC U...	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ...	Class III	Sterling Diagnostics, Inc.
Jul 1, 2016	120 V Neptune 3 Rover, Model Number: 0703-001-000	Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potent...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 24, 2016	2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting acc...	A variation in flute depth on the routers was observed. The variation in flute depth may cause th...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 16, 2016	5.0mm Round Fluted Bur, Super Long	Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to ta...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 16, 2016	6.0mm Round Fluted Bur, Super Long	Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to ta...	Class II	Stryker Instruments Div. of Stryker Corporation

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.