C.R. Bard Recalls
117 recalls on record · November 12, 2014 to May 27, 2026 · Medical Devices
Recalls by year
14
15
16
17
18
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 23, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is
Hazard: Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
November 23, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, In
Hazard: Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
November 23, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Hazard: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
November 23, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Uretera
Hazard: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
November 23, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Hazard: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
November 23, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Sten
Hazard: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
November 16, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081
Hazard: Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
September 21, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Hazard: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
September 21, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Hazard: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
August 17, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for pati
Hazard: An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
August 10, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collect
Hazard: Labeling problem
May 18, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indica
Hazard: The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
April 20, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and contr
Hazard: Complaints were received of restricted/inaccurate flow rate.
April 20, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage i
Hazard: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
April 20, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring
Hazard: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
April 20, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients
Hazard: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
February 24, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 uni
Hazard: Report by a customer of an open package seal.
February 17, 2016Medical DevicesFDA
C.R. Bard, Inc. recalls Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Hazard: Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
November 11, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Hazard: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
September 9, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are
Hazard: Potential breach of the sterile barrier packaging.
August 26, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S.
Hazard: Potential breach of the sterile barrier packaging.
August 26, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermitte
Hazard: Potential breach of the sterile barrier packaging.
August 26, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermitte
Hazard: Potential breach of the sterile barrier packaging.
August 26, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermitte
Hazard: Potential breach of the sterile barrier packaging.
August 26, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermitte
Hazard: Potential breach of the sterile barrier packaging.
April 8, 2015Medical DevicesFDA
C.R. Bard, Inc. recalls Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot #
Hazard: Potential breach of the sterile barrier packaging.
November 12, 2014Medical DevicesFDA
C.R. Bard, Inc. recalls Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the abil
Hazard: The product is non-sterile.