C.R. Bard, Inc. recalls

49 recalls in our records from 2014 to 2026: 49 FDA medical devices.

Recalls with full detail pages

• FDA · Medical devicesClass IMay 28, 2025

  C.R. Bard Inc medical device recall: Bard Minnesota Four Lumen Esophagogastric Tamponade Tube

  Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or…

Earlier and other recalls

These link to the official agency notice.

• FDA · Medical devicesClass IISep 16, 2026

  C.R. Bard Inc medical device recall: Products that contain the Pericare Wipes: Bardex Lubricath Foley… Official notice ↗

  Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

• FDA · Medical devicesClass IIMay 27, 2026

  C.R. Bard Inc medical device recall: Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF:… Official notice ↗

  Due to stain present on the surface of affected foley catheters.

• FDA · Medical devicesClass IIDec 17, 2025

  C.R. Bard Inc medical device recall: Bard InLay Optima Size: 6 Fr. x 14 cm Official notice ↗

  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

• FDA · Medical devicesClass IISep 24, 2025

  C.R. Bard Inc medical device recall: SureStep Foley Tray System Bardex I.C. Complete Care Infection… Official notice ↗

  Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when…

• FDA · Medical devicesClass IISep 3, 2025

  C.R. Bard Inc medical device recall: Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel… Official notice ↗

  Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain,…

• FDA · Medical devicesClass IIJul 9, 2025

  C.R. Bard Inc medical device recall: BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110 Official notice ↗

  Cather packaging may contain the incorrect French size.

• FDA · Medical devicesClass IIJun 26, 2024

  C.R. Bard Inc medical device recall: Bard Medical SureStep Foley Tray System Official notice ↗

  Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

• FDA · Medical devicesClass IIJan 31, 2024

  C.R. Bard Inc medical device recall: Bard Nasogastric Sump Tube with ENFit Official notice ↗

  BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and…

• FDA · Medical devicesClass IIDec 20, 2023

  C.R. Bard Inc medical device recall: Sensica Urine Output System Official notice ↗

  BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a…

• FDA · Medical devicesClass IIJun 14, 2023

  C.R. Bard Inc medical device recall: Magic3 Go Intermittent Urinary Catheters Official notice ↗

  Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product…

• FDA · Medical devicesClass IIJul 6, 2022

  C.R. Bard Inc medical device recall: Sensica Urine Output System Official notice ↗

  Complaints relating to urine output measurement accuracy.

• FDA · Medical devicesClass IIMar 2, 2022

  C.R. Bard Inc medical device recall: Bard Surestep Intermittent Catheter Tray Official notice ↗

  There is a potential to leak from the catheter where it connects to the drain bag

• FDA · Medical devicesClass IISep 29, 2021

  C.R. Bard Inc medical device recall: Catalog A119216M Official notice ↗

  There is potential for packaging defects that may impact the sterile barrier.

• FDA · Medical devicesClass IIApr 28, 2021

  C.R. Bard, Inc. medical device recall: Bard Clean-Cath Intermittent Catheter Official notice ↗

  The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

• FDA · Medical devicesClass IIMay 20, 2020

  C.R. Bard Inc medical device recall: SureStep Foley Tray System - Product Usage: Intended for use in the… Official notice ↗

  There is potential for a white paper-type residue attached to the catheter.

• FDA · Medical devicesClass IIFeb 19, 2020

  C.R. Bard Inc medical device recall: The Bard Intra-abdominal Pressure Monitoring Device is composed of a… Official notice ↗

  Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement…

• FDA · Medical devicesClass IIJun 27, 2018

  C.R. Bard, Inc. medical device recall: CritiCore Automated Urine Output and Temperature Monitor Official notice ↗

  Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

• FDA · Medical devicesClass IIJun 13, 2018

  C.R. Bard, Inc. medical device recall: Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter Official notice ↗

  Foley Catheter with Incorrect Retainer Cap Print

• FDA · Medical devicesClass IIApr 18, 2018

  C.R. Bard, Inc. medical device recall: Bard(R) Premature Infant Feeding Tube Official notice ↗

  BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

• FDA · Medical devicesClass IIApr 11, 2018

  C.R. Bard, Inc. medical device recall: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters… Official notice ↗

  Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

• FDA · Medical devicesClass IIFeb 21, 2018

  C.R. Bard, Inc. medical device recall: Bard(R) Criticore(R) Monitor Official notice ↗

  BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature…

• FDA · Medical devicesClass IIFeb 7, 2018

  C.R. Bard, Inc. medical device recall: Bard Uros Automated Urine Ouptut And Temperature Monitor Official notice ↗

  The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output…

• FDA · Medical devicesClass IIDec 27, 2017

  C.R. Bard, Inc. medical device recall: Medivance ArcticGel Small Pad Kit - a box containing a single foil… Official notice ↗

  Hydrogel peeling from the pads.

• FDA · Medical devicesClass IIDec 27, 2017

  C.R. Bard, Inc. medical device recall: I-125 CE Marked QuickLink Cartridges Official notice ↗

  Activity and quantity of seeds sent in shipments were incorrect.

• FDA · Medical devicesClass IIIDec 13, 2017

  C.R. Bard, Inc. medical device recall: Arctic Sun ArcticGel Pads - Medium Official notice ↗

  Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product…

• FDA · Medical devicesClass IIOct 4, 2017

  C.R. Bard, Inc. medical device recall: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female Official notice ↗

  Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.

• FDA · Medical devicesClass IIAug 23, 2017

  C.R. Bard, Inc. medical device recall: Arctic Sun 5000 Temperature Management System Official notice ↗

  Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.

• FDA · Medical devicesClass IIAug 16, 2017

  C.R. Bard, Inc. medical device recall: BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension Official notice ↗

  Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.

• FDA · Medical devicesClass IIApr 26, 2017

  C.R. Bard, Inc. medical device recall: SURESTEP Tray Official notice ↗

  Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

• FDA · Medical devicesClass IIJan 18, 2017

  C.R. Bard, Inc. medical device recall: SURESTEP Tray Official notice ↗

  The product contained a latex catheter instead of a silicone catheter.

• FDA · Medical devicesClass IIDec 21, 2016

  C.R. Bard, Inc. medical device recall: BARD¿ Irrigation Official notice ↗

  Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

• FDA · Medical devicesClass IINov 23, 2016

  C.R. Bard, Inc. medical device recall: Bard Fluoro-4 Silicone Ureteral Stent Official notice ↗

  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…

• FDA · Medical devicesClass IINov 23, 2016

  C.R. Bard, Inc. medical device recall: C-Max" Cutting Loop Electrodes Official notice ↗

  Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

• FDA · Medical devicesClass IINov 23, 2016

  C.R. Bard, Inc. medical device recall: Magic3 Antibacterial Hydrophilic Intermittent Catheter Official notice ↗

  Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).

• FDA · Medical devicesClass IINov 16, 2016

  C.R. Bard, Inc. medical device recall: X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation… Official notice ↗

  Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

• FDA · Medical devicesClass IISep 21, 2016

  C.R. Bard, Inc. medical device recall: Option-vf Urinary Catheter. Female use only. Latex Free. Sterile Official notice ↗

  During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

• FDA · Medical devicesClass IIIAug 17, 2016

  C.R. Bard, Inc. medical device recall: Medivance ArcticGel Neonatal Pad The pad is designed to fit into an… Official notice ↗

  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…

• FDA · Medical devicesClass IIIAug 10, 2016

  C.R. Bard, Inc. medical device recall: SureStep Tray Official notice ↗

  Labeling problem

• FDA · Medical devicesClass IIMay 18, 2016

  C.R. Bard, Inc. medical device recall: Arctic Sun Temperature Management System Official notice ↗

  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…

• FDA · Medical devicesClass IIApr 20, 2016

  C.R. Bard, Inc. medical device recall: BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature… Official notice ↗

  Complaints were received of restricted/inaccurate flow rate.

• FDA · Medical devicesClass IIApr 20, 2016

  C.R. Bard, Inc. medical device recall: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter Official notice ↗

  Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

• FDA · Medical devicesClass IIIFeb 24, 2016

  C.R. Bard, Inc. medical device recall: REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer… Official notice ↗

  Report by a customer of an open package seal.

• FDA · Medical devicesClass IIFeb 17, 2016

  C.R. Bard, Inc. medical device recall: Arctic Sun 5000 and Arctic Sun 2000 Official notice ↗

  Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the…

• FDA · Medical devicesClass IIINov 11, 2015

  C.R. Bard, Inc. medical device recall: Antibacterial Hydro Personal Catheter Official notice ↗

  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…

• FDA · Medical devicesClass IISep 9, 2015

  C.R. Bard, Inc. medical device recall: Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated… Official notice ↗

  Potential breach of the sterile barrier packaging.

• FDA · Medical devicesClass IIAug 26, 2015

  C.R. Bard, Inc. medical device recall: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters Official notice ↗

  Potential breach of the sterile barrier packaging.

• FDA · Medical devicesClass IIApr 8, 2015

  C.R. Bard, Inc. medical device recall: Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber… Official notice ↗

  Potential breach of the sterile barrier packaging.

• FDA · Medical devicesClass IINov 12, 2014

  C.R. Bard, Inc. medical device recall: Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone… Official notice ↗

  The product is non-sterile.

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.