C.R. Bard Inc recalls Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

Recall date

April 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1759-2025

FDA classification

Class I

Brand / firm

C.R. Bard Inc

Sold / distributed

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

Why it was recalled

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 is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740