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 |
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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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