C.R. Bard, Inc.

Complete recall history across all FDA and CPSC categories — 51 total recalls

C.R. Bard, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (51)

FDA medical device enforcement actions by C.R. Bard, Inc.. Showing most recent 50.

Date Product Reason Class
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 no... Class II
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 ab... Class II
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 ab... Class II
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 ab... Class II
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 ab... Class II
Dec 13, 2017 Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22... Foley Catheter with Incorrect Retainer Cap Print Class II
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 fai... Class II
Nov 10, 2017 CritiCore Automated Urine Output and Temperature Monitor Issues identified with the monitor including urine output measurement errors,... Class II
Oct 16, 2017 Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, whi... Hydrogel peeling from the pads. Class II
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 Temper... Class II
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 som... Class II
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 som... Class II
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 som... Class II
Jul 28, 2017 Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (3... Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter m... Class II
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... Class III
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 potentia... Class II
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 oc... Class II
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 fac... Class II
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
Oct 13, 2016 Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral... Labeling: Statement was added to the Warnings/Precautions section requesting ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
Oct 12, 2016 X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE... Contract manufacturer packaged an incorrect sheath with the product. Package... Class II
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... Class II
Oct 5, 2016 Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box),... Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent... Class II
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 packa... Class II
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 packa... Class II
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 packa... Class II
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 packa... Class II
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 ... Class II
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
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 ... Class II
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... Class III
Jun 29, 2016 SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK St... Labeling problem Class III
Mar 4, 2016 BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management ... Complaints were received of restricted/inaccurate flow rate. Class II
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
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 ... Class II
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 ... Class II
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 ... Class II
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 T... Class II
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 draina... Class II
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 C... Class III
Aug 24, 2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... Potential breach of the sterile barrier packaging. Class II
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, ... Potential breach of the sterile barrier packaging. Class II
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, ... Potential breach of the sterile barrier packaging. Class II
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, ... Potential breach of the sterile barrier packaging. Class II
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the I... Potential breach of the sterile barrier packaging. Class II
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, ... Potential breach of the sterile barrier packaging. Class II
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

View all 51 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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