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
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.