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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
Sep 17, 2014 Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 8, 2014 Xoran MiniCAT X-ray imaging device Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. Class II Xoran Technologies, LLC
Jul 25, 2014 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe ... Unit packages may exhibit open seals which impacts package integrity and potentially product ster... Class II Centurion Medical Products Corporation
Jun 24, 2014 Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Med... The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. ... Class II Stryker Instruments Div. of Stryker Corporation
Jun 17, 2014 Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System ... An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accur... Class II Terumo Cardiovascular Systems Corporation
Jun 17, 2014 Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System ... An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accur... Class II Terumo Cardiovascular Systems Corporation
Jun 11, 2014 Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. T... Lack of Sterility Assurance Class II PIONEER SURGICAL TECHNOLOGY, INC.
Jun 4, 2014 InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, ... Stryker has received complaints from the field alleging instances where the In Touch beds are hoi... Class II Stryker Medical Division of Stryker Corporation
May 29, 2014 Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3... Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-... Class II Kerr Corporation
May 23, 2014 Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, sut... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for ve... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer &... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Us... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flar... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr wit... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with o... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 22, 2014 Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are inte... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are int... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.0mm Barrel Bur Sterile There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The de... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are int... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The dev... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are int... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended ... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: ... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The ... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are ... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The ... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are i... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The dev... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are int... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2014 Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are int... There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... 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.