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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Aug 14, 2024 TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA P... Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fus... Class II Innovasis, Inc
Apr 7, 2020 Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical... Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screw... Class II Innovasis, Inc
Jan 8, 2018 Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletal... Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. Class II Innovasis, Inc
May 5, 2017 Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*.... Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). Class II Innovasis, Inc
Dec 7, 2015 Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod ... Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's la... Class II Innovasis, Inc
Jul 7, 2014 Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm... Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and c... Class II Innovasis, 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.