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Browse Device Recalls

353 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 353 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 353 FDA device recalls.

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DateProductReasonClassFirm
Jan 7, 2015 System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a ... Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a h... Class II Stryker Instruments Div. of Stryker Corporation
Dec 22, 2014 Flyte Togas are components of the Stryker Flyte System and are intended to be... A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled... Class III Stryker Instruments Div. of Stryker Corporation
Oct 8, 2014 Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The Sma... The SmartLife Aseptic Housings are being recalled in that the top section of the housing may sepa... Class II Stryker Instruments Div. of Stryker Corporation
Oct 8, 2014 Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The Sma... The SmartLife Aseptic Housings are being recalled in that the top section of the housing may sepa... Class II Stryker Instruments Div. of Stryker Corporation
Aug 15, 2014 Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp.,... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
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 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 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
May 22, 2014 Stryker 5.0mm 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 Precision Neuro Drill Sterile Product Usage: The d... 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 Tapered Round Elite Bur Sterile Product Usage: The devices... 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 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 13, 2014 The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-co... The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... Class II Stryker Instruments Div. of Stryker Corporation
May 13, 2014 The NAV3i Platform Power Box supplies the electrical components with power (e... The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2014 Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an ele... During packaging verification testing, a failure occurred due to cuts in the packaging potentiall... Class II Stryker Instruments Div. of Stryker Corporation
Mar 18, 2014 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is co... Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the li... Class II Stryker Instruments Div. of Stryker Corporation
Dec 30, 2013 Neptune 2 Rover Ultra Waste Management System The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field ... Class II Stryker Instruments Div. of Stryker Corporation
Dec 30, 2013 Neptune 2 Rover Ultra Waste Management System. The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field ... Class II Stryker Instruments Div. of Stryker Corporation
Dec 27, 2013 The Gaymar Medi-Therm device provides a means of regulating patient temperatu... Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water tem... Class II Stryker Medical Division of Stryker Corporation
Dec 6, 2013 Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4... The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorr... Class II Stryker Instruments Div. of Stryker Corporation
Nov 26, 2013 S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in ... Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds b... Class II Stryker Medical Division 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.