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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
May 1, 2025 BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or ... During the attachment of the needle guide to the covered probe, the tight tolerance and fit of th... Class II Civco Medical Instruments Co. Inc.
Oct 8, 2021 VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class II Civco Medical Instruments Co. Inc.
Oct 8, 2021 VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class II Civco Medical Instruments Co. Inc.
Oct 8, 2021 VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class II Civco Medical Instruments Co. Inc.
Oct 8, 2021 VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class II Civco Medical Instruments Co. Inc.
Jul 30, 2018 CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO The assembly of the needle guides were found to be either missing adhesive or did not have adequa... Class II Civco Medical Instruments Co. Inc.
Jul 30, 2018 CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO The assembly of the needle guides were found to be either missing adhesive or did not have adequa... Class II Civco Medical Instruments Co. Inc.
Feb 23, 2018 CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or ca... A cover failed leak testing during validation testing of new needle guides from a replacement tool. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STE... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Pl... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Gu... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking br... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. 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.