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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
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 16, 2014 Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT200... The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate ... Class I Ventlab LLC
May 15, 2014 Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial... The original mean assigned to the control too high, upon reassignment with additional data the ne... Class III Medtest Holdings, Inc.
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
May 9, 2014 CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 1458... There is a potential for inaccuracies in blood gas readings/measurements. There is a potential ri... Class II Terumo Cardiovascular Systems 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 20, 2014 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSyste... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile ... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile ... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (1... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intend... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) In... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
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
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarn... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarn... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems 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 18, 2013 TopCare Clifford THE BIG RED DOG power toothbrush for kids! Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Cliffo... Class II Ranir Corporation
Dec 18, 2013 UP & UP kids' power toothbrush Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Cliffo... Class II Ranir 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 REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M... Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. Class II Materialise USA LLC
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
Nov 26, 2013 Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically fo... 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
Nov 8, 2013 ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : ... Patient Specific Guide contained the incorrect case report. The case report contains patient spe... Class II Materialise USA LLC
Nov 8, 2013 ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : ... Patient Specific Guide contained the incorrect case report. The case report contains patient spe... Class II Materialise USA LLC
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

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.