Recall Z-1759-2025— C.R. Bard Inc

Name: FDA recall Z-1759-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Class I · Ongoing

Class I FDA medical device recall by C.R. Bard Inc, initiated 2025-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740. Reason: 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..

Recalling firm: C.R. Bard Inc
Classification: Class I
Status: Ongoing
Initiated: 2025-04-17
Firm location: Covington, GA, United States

Product description

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.