Browse Device Recalls

52 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 52 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 52 FDA device recalls.

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DateProductReasonClassFirm
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...
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...
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 16, 2016 RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm... RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ ... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Apr 22, 2016 Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sle... Potential for a product defect where the cannula may be obstructed. This obstruction could preve... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Mar 18, 2016 RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common ... Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip ... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 29, 2015 Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Steril... The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of imp... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 21, 2015 Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)0084... Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored... 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.