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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Date	Product	Reason	Class	Firm
Nov 12, 2021	Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38...	Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin...	Class II	Cook Inc.
Nov 12, 2021	Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-...	Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin...	Class II	Cook Inc.
Oct 13, 2021	Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. R...	Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior...	Class II	Cook Inc.
Oct 8, 2021	Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G0236...	Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not...	Class II	Cook Inc.
Oct 8, 2021	Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Co...	Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not...	Class II	Cook Inc.
Sep 28, 2021	Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G0990...	Affected lots may be manufactured incorrectly with the radiopaque marker band located just below ...	Class II	Cook Inc.
Sep 28, 2021	Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5....	Affected lots may be manufactured incorrectly with the radiopaque marker band located just below ...	Class II	Cook Inc.
Jan 4, 2021	Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for r...	Manufactured with incorrect material, which may result in the stent being stiffer and potentially...	Class II	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Oct 22, 2020	Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved...	Affected product was dropped during manufacturing, which may result in a bent wire guide and/or t...	Class I	Cook Inc.
Aug 31, 2020	Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, ...	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ...	Class II	Cook Inc.
Aug 31, 2020	Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-...	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ...	Class II	Cook Inc.
Aug 11, 2020	Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated ...	May contain excess glue within the handle of the delivery system, resulting in an inability to fu...	Class II	Cook Inc.
Jul 30, 2020	Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Numb...	Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa ...	Class II	Cook Inc.
Jun 2, 2020	Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usag...	Identified products may contain a damaged bushing within the delivery system, which could potenti...	Class II	Cook Inc.
Apr 30, 2020	Pressure Monitoring Tray, C-PMSY, G02854	The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or in...	Class II	Cook Inc.
Apr 30, 2020	Pressure Monitoring Set, C-PMS, G02838	The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or in...	Class II	Cook Inc.
Apr 15, 2020	Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Numb...	The firm received complaints on five devices from one specific lot where the stent dislodged from...	Class II	Cook Inc.
Mar 6, 2020	Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-...	The printed expiration dates are incorrect.	Class II	Cook Inc.
Mar 6, 2020	Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Nu...	The printed expiration dates are incorrect.	Class II	Cook Inc.
Jan 16, 2020	Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is a...	The firm has identified factors which contributed to failures relating to thrombus formation and/...	Class II	Cook Inc.
Dec 27, 2019	Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3...	Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, whi...	Class II	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 ...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 ...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Oct 21, 2019	Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph...	The potential compromise of the sterility of products from an undersealed chevron in the packagin...	Class II	Cook Inc.
Oct 21, 2019	Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph...	The potential compromise of the sterility of products from an undersealed chevron in the packagin...	Class II	Cook Inc.
Oct 21, 2019	Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph...	The potential compromise of the sterility of products from an undersealed chevron in the packagin...	Class II	Cook Inc.
Oct 21, 2019	Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph...	The potential compromise of the sterility of products from an undersealed chevron in the packagin...	Class II	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.