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
Jan 15, 2021 CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm 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, 5 Level, 85mm 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, 1 Level, 24m 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, 34mm 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, 40mm 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, 1 Level, 14mm 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, 1 Level, 12mm 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, 42mm 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, 36mm 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, 3 Level, 42mm 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, 28mm 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, 1 Level, 10mm 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, 30mm 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, 4Level, 60mm 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, 3Level, 57mm 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, 1 Level, 18mm 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, 5 Level, 80mm 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, 1 Level, 20mm 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, 4Level, 80mm 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, 4Level, 68mm 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, 5 Level, 95mm 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, 5 Level, 100mm 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, 4Level, 72mm 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, 3Level, 60mm 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, 24mm 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, 4Level, 64mm 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, 5 Level, 75mm 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, 5 Level, 90mm 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, 3Level, 51mm 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, 3Level, 54mm 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, 4Level, 76mm 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, 4Level, 88mm 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, 1 Level, 22mm 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, 3 Level, 45mm 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, 38mm 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, 3Level, 63mm 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, 3 Level, 48mm Material Nu... Locking mechanism has been observed to disassociate either intraoperatively or postoperatively re... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Dec 28, 2020 Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic ... A failure can occur if the user attempts to remove the device by partially snipping the edge and ... Class II Mar-Med Co
Dec 14, 2020 EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measu... Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may ... Class II Phadia US Inc
Nov 11, 2020 (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir,... Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) Class II Terumo Cardiovascular Systems Corporation
Oct 16, 2020 Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, si... Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to... Class II Stryker Instruments Div. of Stryker Corporation
Oct 5, 2020 Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26... FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a... Class II Micro-Tech Usa
Sep 24, 2020 Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-3... System does not include a drill guide. Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Sep 24, 2020 Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-... The Streamline Navigation System taps have experienced binding with other devices. Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Sep 24, 2020 Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-6... The Streamline Navigation System taps have experienced binding with other devices. Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Sep 11, 2020 Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN ... The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Sep 11, 2020 VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a compon... VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a seconda... Class II Skytron, Div. The KMW Group, Inc
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Ca... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems Corporation
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems Corporation
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems 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.