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 |
|---|---|---|---|---|
| Feb 1, 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | 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 LG, Part ID 16816 | 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 MD, Part ID 16814 | 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 M/L, Part ID 17037 | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... | Class II | BioPro, Inc. |
| Jan 21, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und... | A risk for product contamination was identified for the affected product lot. If used, there is a... | Class II | NeuMoDx Molecular Inc |
| Jan 20, 2022 | PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for cur... | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. | Class II | Envisiontec US Llc |
| Jan 6, 2022 | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 6, 2022 | FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Dec 22, 2021 | 8mm FlexDex Needle Driver, Product Code FD-335 ND | The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon ins... | Class II | FlexDex Inc. |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Dec 9, 2021 | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... | Class II | DIXI MEDICAL USA |
| Jul 23, 2021 | Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code... | Affected products were manufactured with materials found to have a bioburden level exceeding the ... | Class II | Aspen Surgical Products, Inc. |
| Jul 23, 2021 | Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product cod... | Affected products were manufactured with materials found to have a bioburden level exceeding the ... | Class II | Aspen Surgical Products, Inc. |
| Jul 23, 2021 | Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample K... | Affected products were manufactured with materials found to have a bioburden level exceeding the ... | Class II | Aspen Surgical Products, Inc. |
| Jun 8, 2021 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #... | intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calib... | Class II | Terumo Cardiovascular Systems Corporation |
| May 12, 2021 | Prime TC-transport chair intended for medical purposes to assist a person in... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Isolibrium Support Surface - support surface assists in the prevention and tr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | TruRize Clinical Chair - support structure that places human occupants in upr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four buil... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Surgistool-intended to support a healthcare professional during surgical proc... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | IsoGel Air - support surface assists in the prevention and treatment of all p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Symmetry Plus Treatment Recliner - general hospital use as a convenient seati... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | ComfortGel - assists in the prevention and treatment of all pressure injury s... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Stretcher Chair-for use in all acute care hospitals and medical outpatient se... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CUB Pediatric Crib- intended to provide a pediatric patient support surface f... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Transport Stretcher 747 - a non-powered, wheeled device designed to support p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | InTouch 2131-intended to support a human patient in an acute care setting, M... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Michael Graves with Stryker Highback Chair-intended for pediatric and adult p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Proform- support surface is used to assist in the prevention and treatment of... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and sh... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 11, 2021 | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounti... | Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time a... | Class II | Skytron, Div. The KMW Group, Inc |
| May 4, 2021 | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx... | There is a potential for false positive results when certain lots of cartridges are used in conju... | Class II | NeuMoDx Molecular Inc |
| Apr 16, 2021 | The Terumo HX2 Temperature Management System provides temperature control of ... | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 16, 2021 | The Sarns Temperature Control and Monitor unit (TCM) is a source of temperatu... | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 16, 2021 | The Sarns TCM II (system) is a source of temperature-controlled water for blo... | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material N... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Nu... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| Jan 15, 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Num... | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
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.