CLASS I ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

Bard Blakemore Esophageal-Nasogastric Tube (Adult) recalled by C.R. Bard

C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tube (Adult), distributed in 44 states. The recall was initiated on 17 Apr 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lots within expiration/UDI: (01)00801741076800
Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1756-2025
FDA event ID
96645
Recalling firm
C.R. Bard, Covington, GA
Classification
Class I
Status
Ongoing
Recall initiated
17 Apr 2025
FDA classified
20 May 2025
Reported
28 May 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material

Timeline

17 Apr 2025Recall initiated by company
20 May 2025Classified by FDA+33 days
28 May 2025Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri

Questions about this recall

Why was it 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.

Which lots are affected?

All Lots within expiration/UDI: (01)00801741076800

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 96645

This product is part of a recall event; the main page for the event is Bard¿ Single Intragastric Linton Balloon Tube recalled by C.R. Bard.

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