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Browse Device Recalls

70 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 70 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 70 FDA device recalls.

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DateProductReasonClassFirm
Feb 24, 2015 LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste... Mislabeled with an incorrect expiration date Class III LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboG... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Mar 18, 2013 LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 18, 2013 Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, 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.