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Browse Device Recalls

161 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 161 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 161 FDA device recalls.

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DateProductReasonClassFirm
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
Jun 14, 2016 Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687... The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Va... Class II Stryker Instruments Div. of Stryker Corporation
Apr 28, 2016 Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic... Due to the buildup of grease within the hose and motor, the product may require multiple attempts... Class II Stryker Instruments Div. of Stryker Corporation
Mar 22, 2016 Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw ... The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembl... Class II Stryker Instruments Div. of Stryker Corporation
Mar 21, 2016 SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model nu... The affected scanner does not correctly interact with the SC360 software. When docked pre/postope... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with insert... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Nov 23, 2015 Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units ... The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date o... Class II Stryker Instruments Div. of Stryker Corporation
Jul 20, 2015 Neptune 2 Waste Management System Docking Station (120V and 230V), New and Re... The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be ... Class II Stryker Instruments Div. of Stryker Corporation
Jun 2, 2015 Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: ... Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the p... Class II Stryker Instruments Div. of Stryker Corporation
May 22, 2015 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (... Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to compla... Class II Stryker Instruments Div. of Stryker Corporation
May 8, 2015 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare... Potential sterility breach in the packaging. Class II Stryker Instruments Div. of Stryker Corporation
May 4, 2015 Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103... Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm becaus... Class II Stryker Instruments Div. of Stryker Corporation
Apr 24, 2015 EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLi... Potential for the device cannula to overthrow past the intended length. Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Troc... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main c... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tr... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 25, 2015 Universal Charger Product Usage: The Stryker Universal Battery Charg... The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... Class III Stryker Instruments Div. of Stryker Corporation
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
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
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

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.