Bard Intragastric Balloon Tube (C.R. Bard) – Plug Removal (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard Single Intragastric Linton Balloon Tube, REF: 0092740
Brand
C.R. Bard Inc
Lot Codes / Batch Numbers
All Lots within expiration/UDI: (01)00801741076848
Products Sold
All Lots within expiration/UDI: (01)00801741076848
C.R. Bard Inc is recalling Bard Single Intragastric Linton Balloon Tube, REF: 0092740 due to 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 ga. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On April 17, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Correction" Notification to affected consignees. BD asked consignees to take the following actions: 1. Follow the above plastic plug removal instructions. 2. Post this notice where the devices are stored. 3. Please check all inventory locations within your institution for affected products 4. Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred 5.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of this notification 6.Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026