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Browse Device Recalls

29 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 29 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 29 FDA device recalls.

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DateProductReasonClassFirm
Apr 3, 2025 MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; Devices for the affected lot were not assembled according to product specifications. The distrac... Class II Globus Medical, Inc.
Dec 15, 2023 ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 7, 2023 ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP... Class I Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Jul 22, 2020 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... Class II Globus Medical, Inc.
Aug 28, 2013 Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse ... The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. Class II Globus Medical, 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.