Bard Minnesota Esophagogastric Tamponade Tubes Recalled for Plastic Plug Removal Difficulty
The FDA recalls Bard Minnesota Esophagogastric Tamponade Tubes due to difficulty removing plastic plugs needed to inflate the therapeutic balloons, which may prevent proper device function.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I, the most serious category for medical devices, which requires a minimum severity score of 4. The malfunction prevents users from inflating the therapeutic balloons in an emergency hemostasis device, directly compromising its critical function, although no adverse health consequences have been reported.
Plain-English summary
Bard Minnesota Four Lumen Esophagogastric Tamponade Tubes (Model REF:0092220) are being recalled by the FDA due to customer complaints about difficulty removing the plastic plugs that must be removed to inflate the gastric and esophageal balloons.
The esophagogastric tamponade tube is a medical device used in emergency treatment to control bleeding in the esophagus and stomach. The device functions by inflating balloons to apply pressure to the bleeding site. When users cannot remove the plastic plugs, they are unable to inflate the balloons, preventing the device from performing its intended function.
The recalled devices are identified by UDI (01)00801741076824 and include all lots within the product's expiration date. Distribution has been widespread across the United States, Puerto Rico, and internationally to Canada, United Kingdom, Singapore, Belgium, Netherlands, Ireland, Sweden, and South Africa.
Users should contact C.R. Bard Inc for information about the recall and instructions for device replacement or return.
The recalled product
- Product
- Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
- Manufacturer
- C.R. Bard Inc
- Hazard
- device-malfunction
- usability-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots within expiration/UDI: (01)00801741076824
Distribution
Distributed in 51 states:
- 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
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