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Browse Device Recalls

55 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 55 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 55 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, uro... The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. Class II C.R. Bard, Inc.
Feb 27, 2018 Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product U... BMD has identified that the product code/lot number combination identified above may have ineffec... Class II C.R. Bard, Inc.
Feb 27, 2018 Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BAR... BMD has identified that the product code/lot number combination identified above may have ineffec... Class II C.R. Bard, Inc.
Feb 27, 2018 Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Us... BMD has identified that the product code/lot number combination identified above may have ineffec... Class II C.R. Bard, Inc.
Feb 27, 2018 Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product U... BMD has identified that the product code/lot number combination identified above may have ineffec... Class II C.R. Bard, Inc.
Dec 13, 2017 Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22... Foley Catheter with Incorrect Retainer Cap Print Class II C.R. Bard, Inc.
Nov 10, 2017 BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Autom... BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urin... Class II C.R. Bard, Inc.
Nov 10, 2017 CritiCore Automated Urine Output and Temperature Monitor Issues identified with the monitor including urine output measurement errors, temperature measure... Class II C.R. Bard, Inc.
Oct 16, 2017 Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, whi... Hydrogel peeling from the pads. Class II C.R. Bard, Inc.
Sep 29, 2017 BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M ... The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may le... Class II C.R. Bard, Inc.
Sep 14, 2017 Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter... Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath... Class II C.R. Bard, Inc.
Sep 14, 2017 Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, ... Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath... Class II C.R. Bard, Inc.
Sep 14, 2017 HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box,... Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath... Class II C.R. Bard, Inc.
Jul 28, 2017 Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (3... Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophi... Class II C.R. Bard, Inc.
Jun 2, 2017 Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 Label on product box contains the incorrect reference #317-09 while the shelf box label with barc... Class III C.R. Bard, Inc.
Jun 2, 2017 BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension... Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the prod... Class II C.R. Bard, Inc.
Mar 31, 2017 Arctic Sun 5000 Temperature Management System, 100-120 V North America and 10... Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continu... Class II C.R. Bard, Inc.
Mar 9, 2017 SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, ... Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural ru... Class II C.R. Bard, Inc.
Dec 9, 2016 I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive ... Activity and quantity of seeds sent in shipments were incorrect. Class II C.R. Bard, Inc.
Oct 13, 2016 Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 13, 2016 Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coi... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 13, 2016 BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covingt... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 13, 2016 Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Co... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 12, 2016 X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE... Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. Class II C.R. Bard, Inc.
Oct 12, 2016 C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Steri... Defect; The contact part could possibly separate from the electrode affecting to functionality of... Class II C.R. Bard, Inc.
Oct 5, 2016 Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box),... Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instea... Class II C.R. Bard, Inc.
Aug 3, 2016 BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 3, 2016 BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 3, 2016 BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 3, 2016 BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Jul 11, 2016 Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. During an FDA inspection it was found out that the Practical Foley Catheters to be potentially no... Class II C.R. Bard, Inc.
Jul 11, 2016 SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK S... The product contained a latex catheter instead of a silicone catheter. Class II C.R. Bard, Inc.
Jul 11, 2016 Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. During an FDA inspection it was found out that the Practical Foley Catheters to be potentially no... Class II C.R. Bard, Inc.
Jun 30, 2016 Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incuba... An internal review of an available product found that the Information For Use only contained Engl... Class III C.R. Bard, Inc.
Jun 29, 2016 SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK St... Labeling problem Class III C.R. Bard, Inc.
Mar 4, 2016 BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management ... Complaints were received of restricted/inaccurate flow rate. Class II C.R. Bard, Inc.
Jan 4, 2016 REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapte... Report by a customer of an open package seal. Class III C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for u... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bla... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Nov 10, 2015 Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling... Improper targeted temperature therapy was delivered to patients because the Temperature Simulator... Class II C.R. Bard, Inc.
Nov 9, 2015 Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The pr... The product may contain electronic components that lead to a premature drainage of the internal c... Class II C.R. Bard, Inc.
Oct 2, 2015 Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold i... Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Cathet... Class III C.R. Bard, Inc.
Aug 24, 2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the I... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jan 30, 2015 Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard E... Potential breach of the sterile barrier packaging. Class II C.R. Bard, 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.