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FDA · Medical devicesClass I

C.R. Bard Inc medical device recall: Bard Minnesota Four Lumen Esophagogastric Tamponade Tube

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
96645
Recall initiated
Apr 17, 2025
Classified by FDA
May 20, 2025
Posted in Enforcement Report
May 28, 2025
Recalling firm
C.R. Bard Inc
Firm location
Covington, GA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
5

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Apr 17, 2025. FDA classified it 33 days later, on May 20, 2025. This recall event covers 5 separate products, each with its own FDA recall number. Distribution reported by FDA: 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 C.R. Bard Inc has 49 recalls in our records.

Recalled products (5)

  • Z-1755-2025 Class I Ongoing

    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

    Codes / lots: All Lots within expiration/UDI: (01)00801741076824

  • Z-1756-2025 Class I Ongoing

    Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100

    Codes / lots: All Lots within expiration/UDI: (01)00801741076800

  • Z-1757-2025 Class I Ongoing

    Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110

    Codes / lots: All Lots within expiration/UDI: (01)00801741076817

  • Z-1758-2025 Class I Ongoing

    Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

    Codes / lots: All Lots within expiration/UDI: (01)00801741076831

  • Z-1759-2025 Class I Ongoing

    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

    Codes / lots: All Lots within expiration/UDI: (01)00801741076848

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 96645
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.