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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 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 50mm 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 Set Screw. 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 Block. 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 35mm. 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 Dilator B. 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 MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pe... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spin... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. 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 MIS Alignment Driver. 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 Anti Torque Device. 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 Rod Checker and T-Bar. 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 60mm 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 Poly Screw 7.5 x 50mm. 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 Torque Handle. 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 Poly Screw 6.5 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 Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spi... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Marking Pin (Smooth). 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 MIS Screw 5.5 x 40mm and 5.5 x 4.0 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 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 Poly Screw 7.5 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 Small 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 Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIM... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Tapper 5.5. 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 Poly Screw 7.5 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 MIS Screw 5.5 x 50mm and 5.5 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 5.5 x 05mm Curved Rod. 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 Poly Screw 5.5 x 30mm. 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 Anti Torque. 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 Open Extension (Small). 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 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 7.5 x 50mm screw. 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 Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Screw Spina... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 300mm 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 Rod Checker. 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 Poly Screw 5.5 x 35mm. 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 Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixatio... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 5.5 mm Instrument Tap. 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 80mm 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 Poly Screw 5.5 x 30mm. 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 Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS P... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 35mm 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 400mm 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 Open Extension (Large). 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 Wall Check. 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 MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. Part of ... 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 Closed Extension. 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 Rod Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... 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.