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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
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 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 4, 2013 Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single u... Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor... Class II Stryker Instruments Div. of Stryker Corporation
Nov 1, 2013 Acetabular Pressurizer; single use and six units per box. The Acetabular P... On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer ... Class II Stryker Instruments Div. of Stryker Corporation
Oct 2, 2013 REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance Syste... It was discovered that the silicone potting failed to properly cure after undergoing the prescrib... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013 Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performan... The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013 CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used wit... The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... Class II Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013 RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and T... The safety margin values detailed in the Engineering Design were entered incorrectly into the pro... Class II Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013 Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Pro... A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C... Class II Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013 Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product ... A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C... Class II Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013 Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product... A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C... Class II Stryker Instruments Div. of Stryker Corporation
Jun 16, 2013 The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging ... Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading informat... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... 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.