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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 Dilator Handle. 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 35mm 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 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 Rod Gauge. 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 5.5 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 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 MIS Tapper 5.5mm. 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 Extension Guide Bush. 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 70mm 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 7.5 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 50mm 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 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Sc... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 80mm 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 Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 80mm 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 Rod Pusher B. 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 30mm Rod. 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 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 35mm Rod. 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 Dilator A. 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 6.5 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 Ratchet T Handle. 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 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 MIS Screw 6.5 x 40mm. 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 60mm 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 55mm 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 Screw 6.5 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 MIS Poly Screw Driver B. 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 MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedic... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS C. 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 Poly Screw 6.5 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 Poly Screw 6.5 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 Pedicle Cut. 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 Distractor. 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 7.5 x 40mm. 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 Guide Wire. 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 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Sc... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 5.5 x 35mm 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 MIS Screw 6.5 x 40mm and 6.5 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 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 40mm Rod. 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 Body Alignment Driver. 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 Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fi... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... 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.