C.R. Bard Inc

17 FDA enforcement actions

17 Total Recalls

5 Class I

12 Class II

0 Class III

Firm Details

Product Types: device
States: GA

All Recalls

Class II: Risk 11/06/2025 device

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II: Risk 11/06/2025 device

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II: Risk 11/06/2025 device

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II: Risk 11/06/2025 device

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class II: Risk 07/17/2025 device

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 it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class II: Risk 07/17/2025 device

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 it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class II: Risk 07/17/2025 device

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 it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class II: Risk 06/18/2025 device

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, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Class II: Risk 06/03/2025 device

Cather packaging may contain the incorrect French size.
Class II: Risk 06/03/2025 device

Cather packaging may contain the incorrect French size.
Class II: Risk 06/03/2025 device

Cather packaging may contain the incorrect French size.
Class I: Dangerous 04/17/2025 device

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 esophageal balloons.
Class I: Dangerous 04/17/2025 device

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 esophageal balloons.
Class I: Dangerous 04/17/2025 device

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 esophageal balloons.
Class I: Dangerous 04/17/2025 device

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 esophageal balloons.
Class I: Dangerous 04/17/2025 device

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 esophageal balloons.
Class II: Risk 05/09/2024 device

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.