FDAClass IMay 28, 2025

Bard¿ Single Intragastric Linton Balloon Tube recall

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

Why was Bard¿ Single Intragastric Linton Balloon Tube 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots within expiration/UDI: (01)00801741076848

Product
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Recalling firm
C.R. Bard Inc
Quantity
N/A
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
Recall date
May 28, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls