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Browse Device Recalls

144 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 144 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 144 FDA device recalls.

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DateProductReasonClassFirm
Jun 21, 2017 PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fix... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMI... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Ped... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pe... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Sp... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 40mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 7.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 45mm MIS . Part of MAXIMIS Pedicle Screw Spinal Fixation Sys... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Tapper 6.5. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Extension Sleeve. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 40mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pe... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation Syste... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fix... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC

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.