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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 10, 2026 Artegraft Vascular Graft; REF#: AG740; Labeling mix-up resulting in the incorrect lot outer packaging of product. Class II LeMaitre Vascular, Inc.
Sep 25, 2025 Artegraft¿ Collagen Vascular Graft; REF: AG1015; The device was incorrectly packed in the wrong size labeled outer packaging. Class II LeMaitre Vascular, Inc.
Sep 2, 2025 Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3... The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced u... Class II LeMaitre Vascular, Inc.
Aug 25, 2025 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a... Class II LeMaitre Vascular, Inc.
Apr 11, 2025 Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. During internal product testing, it was observed that some packages to have incomplete seals (ste... Class II LeMaitre Vascular, Inc.
Apr 11, 2025 TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651... During internal product testing, it was observed that some packages to have incomplete seals (ste... Class II LeMaitre Vascular, Inc.
Apr 11, 2025 Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-... During internal product testing, it was observed that some packages to have incomplete seals (ste... Class II LeMaitre Vascular, Inc.
Apr 17, 2024 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular gra... The guide tip can become damaged and result in the tip detaching. Class II LeMaitre Vascular, Inc.
Jul 13, 2023 The Chevalier Valvulotome is a device used to disrupt the valves of veins whi... Burrs (molding flash) on the cutter may tear the harvested vien Class II LeMaitre Vascular, Inc.
Sep 30, 2022 TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon ... Three lots tied by two trainees were released without performing the required pull test. If tied ... Class II LeMaitre Vascular, Inc.
Apr 6, 2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... The firm received a complaint regarding particulate found in the packaging foam that could contam... Class II LeMaitre Vascular, Inc.
Mar 23, 2020 LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165... There has been an increased trend in reports of catheters failing to deflate during use, which ma... Class I LeMaitre Vascular, Inc.
Jul 24, 2019 The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a late... incorrect device size being listed on the impacted device packaging Class II LeMaitre Vascular, Inc.
Oct 1, 2018 LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile ... Pouches from this lot are not sealed compromising the sterility Class II LeMaitre Vascular, Inc.
Jun 19, 2018 AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penet... The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU... Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (pap... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (e... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e240... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIF... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF #... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Intr... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Cl... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Cl... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 2... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip ... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip C... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip ... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Jun 22, 2016 AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip C... US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... 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.