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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.