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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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DateProductReasonClassFirm
Feb 23, 2018 T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-1... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal pr... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal prot... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal pro... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protec... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-1... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal prote... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 23, 2018 T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protecti... Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class II Stryker Instruments Div. of Stryker Corporation
Feb 13, 2018 Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Produ... A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob wil... Class III Michigan Instruments, Inc.
Jan 19, 2018 Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provi... Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for... Class II Terumo Cardiovascular Systems Corporation
Dec 18, 2017 ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoC... The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. Class II Phadia US Inc
Dec 18, 2017 ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP ... The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. Class II Phadia US Inc
Dec 14, 2017 DermaPro Waterproof Silicone Tape, SNS57232 The recalling firm received a customer complaint stating the tape was difficult to peel off the r... Class II Safe N Simple, LLC
Nov 9, 2017 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. ... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)45465400394... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Pre... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)761325250... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)76132... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UD... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: ... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 9, 2017 Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 060... Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... Class II Stryker Instruments Div. of Stryker Corporation
Nov 7, 2017 T/Pump temperature therapy pump, Models TP700 and TP700C The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence,... Class III Stryker Medical Division of Stryker Corporation
Oct 23, 2017 CIRCUMCISION TRAY 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 23, 2017 ST. CHRISTOPHER'S SECUREMENT 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 23, 2017 PEDIATRIC IV & IV START KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 SKIN STAPLE REMOVER 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 23, 2017 WOUND CLOSURE TRAY - FACIAL Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 TUBING CHANGE KIT 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 23, 2017 INCISION & DRAINAGE TRAY or KIT 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 23, 2017 WOUND CARE KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 EXCISION TRAY Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 MINOR DRESSING CHANGE TRAY 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 23, 2017 BLOOD DRAW KIT 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 23, 2017 SorbaView Shield Dressing Change Tray 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 23, 2017 MINI PLASTICS 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 23, 2017 INFANT IV SECUREMENT KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 IV START KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 NEONATAL IV START KIT Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 CATHETER SECUREMENT SYSTEM 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 23, 2017 LATEX FREE IV START SET Convenience Kit containing components to assist practitioner with IV placement and securement. Class II Centurion Medical Products Corporation
Oct 23, 2017 SUTURE REMOVAL TRAY, SET or KIT 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 23, 2017 GENERAL PURPOSE INSTRUMENT TRAY Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as... Class II Centurion Medical Products 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.