Browse Device Recalls

949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 949 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 949 FDA device recalls in MI.

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DateProductReasonClassFirm
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-100. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakawa... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, All... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 1, 2023 GS70 Salus Surgical Table, Product Code 18-070-70 When the control of the operating table was used in Bluetooth mode, the operating table continued... Class II Skytron, LLC
Aug 1, 2023 GS70H Salus Surgical Table, Product Code 18-071-70 When the control of the operating table was used in Bluetooth mode, the operating table continued... Class II Skytron, LLC
Jul 10, 2023 SurgiCount+ Software Application-indicated as an adjunctive technology for au... Potential for current software to miscount when scanning in multiple sponge-products from the sam... Class II Stryker Corporation
Jun 28, 2023 The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be us... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone ... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone c... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
May 24, 2023 Power-PRO 2- A powered ambulance cot that consists of a platform, including a... Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... Class II Stryker Medical Division of Stryker Corporation
May 24, 2023 NeuMoDx Cartridge-used for extraction, purification, amplification and detect... Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied d... Class II NeuMoDx Molecular Inc
May 15, 2023 NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... Potential for lot number discrepancies between the test strip packaging and the barcode label app... Class III NeuMoDx Molecular Inc
May 1, 2023 EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 1241... Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE com... Class II Phadia US Inc
May 1, 2023 Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measure... Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE com... Class II Phadia US Inc
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Feb 1, 2023 Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from ... Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and fo... Class II Stryker Medical Division of Stryker Corporation
Jan 25, 2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Jan 25, 2023 Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the ... Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... Class II Stryker Corporation
Dec 22, 2022 AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size ... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Dec 22, 2022 Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size RE... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Nov 11, 2022 Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (Intern... Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury ... Class II Stryker Medical Division of Stryker Corporation
Sep 8, 2022 Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 The kits are being recalled due to a lack of sterility of a spare needle contained within the kit... Class II SunMed Holdings, LLC
Jul 13, 2022 ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number S... MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case ... Class II Materialise USA LLC
Jun 24, 2022 Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in cra... There is a potential for the core diameter to be undersized, which may lead to the router breakin... Class II Stryker Instruments
Jun 15, 2022 SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge t... Class II Stryker Instruments Div. of Stryker Corporation
Jun 2, 2022 Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A Under certain circumstances, the mounting screws may loosen or pull out from the attachment point... Class II Skytron, Div. The KMW Group, Inc
May 13, 2022 NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for ... Class II NeuMoDx Molecular Inc
Feb 18, 2022 NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems ... Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used i... Class II NeuMoDx Molecular Inc
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.

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.