The Recall Desk

Manufacturer

C.R. Bard, Inc.

117 recalls in our database name C.R. Bard, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
117
Critical
0
Severe
6
Most recent
2026-05-27

Of the 117 recalls from C.R. Bard, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–117 of 117

  • LowFDA (Devices)·Z-2333-2016·2016-08-10

    C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues

    C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.

    Product
    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2016·2016-05-18

    C.R. Bard Recalls Arctic Sun Temperature Management Systems

    C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.

    Product
    Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1395-2016·2016-04-20

    C.R. Bard Recalls ArcticGel Pads Due to Flow Rate Issues

    C.R. Bard is recalling 21,412 ArcticGel Pads used with the Arctic Sun Temperature Management System because of complaints regarding restricted or inaccurate flow rates.

    Product
    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1359-2016·2016-04-20

    C.R. Bard Recalls Foley Catheters Due to Labeling Error

    C.R. Bard is recalling 1.4 million latex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1358-2016·2016-04-20

    Bard Foley Catheter Recall Due to Incorrect Inflation Volume Labeling

    C.R. Bard is recalling 1.4 million Bardex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1357-2016·2016-04-20

    Bard Foley Catheter Recalled for Incorrect Inflation Volume Labeling

    C.R. Bard is recalling 1.4 million Bardex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0812-2016·2016-02-24

    C.R. Bard Recalls Toomey Syringes Due to Open Package Seal

    C.R. Bard is recalling 15,400 units of 70cc Toomey Syringes because a customer reported an open package seal.

    Product
    REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0760-2016·2016-02-17

    C.R. Bard Recalls Arctic Sun 5000 and 2000 Temperature Monitors

    C.R. Bard is recalling Arctic Sun 5000 and 2000 devices because a simulator key could be connected to the patient cable, resulting in improper temperature therapy.

    Product
    Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2016·2015-11-11

    C.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error

    C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.

    Product
    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2015·2015-09-09

    C.R. Bard Recalls Magic3 Intermittent Catheters Due to Sterile Barrier Breach

    C.R. Bard is recalling 8,970 Magic3 Intermittent Catheters because the sterile barrier packaging may be breached, potentially compromising sterility.

    Product
    Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2384-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling 14,310 units of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2015·2015-08-26

    C.R. Bard Recalls Magic3 Intermittent Urinary Catheters Due to Sterile Breach

    C.R. Bard is recalling 91,140 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2388-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters for Sterile Breach

    C.R. Bard is recalling 534,972 Magic3 Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2386-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters

    C.R. Bard is recalling 37,686 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2387-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling specific lots of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1358-2015·2015-04-08

    Bard Urinary Drainage Bags Recalled for Potential Sterile Barrier Breach

    C.R. Bard is recalling specific lots of urinary drainage bags due to a potential breach of the sterile barrier packaging.

    Product
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2015·2014-11-12

    C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets

    C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.

    Product
    Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, s
    Category
    Medical Device
    Distribution
    9 states