C.R. Bard Inc: Device Recall

Recall #Z-1759-2025 · 04/17/2025

Class I: Dangerous

Recall Details

Recall Number: Z-1759-2025
Classification: Class I
Product Type: Device
Recalling Firm: C.R. Bard Inc
Status: Ongoing
Date Initiated: 04/17/2025
Location: Covington, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

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.

Product Description

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

Distribution Pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom

Other Recalls by C.R. Bard Inc

Class II: Risk 11/06/2025

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

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

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

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

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

View all recalls by C.R. Bard Inc →

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.