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Browse Device Recalls

262 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 262 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 262 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2017 Coons Interventional Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Jul 31, 2017 Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregn... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
May 9, 2017 Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide ga... Correction to the product Instructions for Use because the current reprocessing instructions do n... Class II Cook Inc.
May 3, 2017 Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endo... Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor V... Class II Cook Inc.
May 3, 2017 OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxid... Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because... Class II Cook Inc.
May 1, 2017 Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethyl... COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... Class II Cook Inc.
May 1, 2017 Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene o... COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... Class II Cook Inc.
May 1, 2017 LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide... COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... Class II Cook Inc.
May 1, 2017 Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized ... COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... Class II Cook Inc.
May 1, 2017 LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open pac... COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... Class II Cook Inc.
May 1, 2017 Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by... COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... Class II Cook Inc.
Apr 25, 2017 Pereyra Ligature Carrier 75 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Pereyra-Raz Ligature Carrier reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Endoscopic Introducer/Extractor reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Stamey Needle reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Clarke-Reich Laparoscopic Knot Pusher reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Mar 7, 2017 Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Cat... Product may overheat, melt, and burn patient. Class II Cook Inc.
Feb 1, 2017 Flexor Radial Access Set, Individual product is packaged in a Tyvek-film ster... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene val... Class II Cook Inc.
Feb 1, 2017 Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in ... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-fil... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-f... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Micropuncture Check-Flo Performer Introducer Set, Individual product is packa... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Nov 28, 2016 Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Ca... Cook Medical has received reports of the trays containing the incorrect needle, which in some cas... Class II Cook Inc.
Jun 24, 2016 Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-... Potential coating contamination with glass particles. Class I Cook Inc.
Apr 15, 2016 White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for th... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Inten... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The cathe... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Inje... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in ob... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Cathete... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Int... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used i... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, ... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diag... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters ... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for s... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Jan 27, 2016 UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consi... Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... Class II Cook Inc.
Jan 27, 2016 Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral ... Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... Class II Cook Inc.
Jan 20, 2016 Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70... Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. Class II Cook Inc.
Jan 8, 2016 Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localizati... Product potentially exposed to body fluids during processing. Potential adverse events that may ... Class II Cook Inc.
Jan 6, 2016 Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Single Lumen Central Venous Catheter Sets and Trays The subject sets and t... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook 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.