FDA recall Z-1759-2025

C.R. Bard Inc · Class I · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-04-17
Report date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1759-2025