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Browse Device Recalls

17 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 17 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 17 FDA device recalls.

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DateProductReasonClassFirm
Aug 31, 2020 Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 31, 2020 Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 31, 2020 Langston Dual Lumen Catheter The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 31, 2020 Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Mar 16, 2020 Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ... The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
May 4, 2018 Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9c... The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a p... Class II Vascular Solutions, Inc.
Apr 25, 2017 Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS... Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a pot... Class I Vascular Solutions, Inc.
Apr 12, 2017 Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxi... The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the ... Class II Vascular Solutions, Inc.
Jan 12, 2017 GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. ... Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf lif... Class II Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 523... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterili... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Mar 4, 2016 Guardian II Hemostasis Valve, models 8210 and 8211. The following models are... Vascular Solutions became aware of a potential problem with the click version of the Guardian II ... Class I Vascular Solutions, Inc.
May 27, 2014 Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions... The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub du... Class I Vascular Solutions, Inc.
Feb 27, 2013 Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, us... Risk that air may be introduced into the device which may lead to an air embolism. Class I Vascular Solutions, Inc.
Jan 29, 2013 Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide... Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross m... Class II Vascular Solutions, Inc.
Aug 30, 2012 Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,... Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal fr... Class II Vascular Solutions, 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.