FDAFDA · Food and drugs·Recall number Z-1759-2025
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Published May 28, 2025 · Recall initiated: April 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard Inc
- Distributor
- 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
- Lot
- All Lots within expiration/UDI: (01)00801741076848
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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