CLASS I ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report
Bard¿ Single Intragastric Linton Balloon Tube recalled by C.R. Bard
C.R. Bard is recalling Bard¿ Single Intragastric Linton Balloon Tube, distributed in 44 states. The recall was initiated on 17 Apr 2025 and the FDA has classified it as Class I.
Check your package
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-1759-2025
- 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
- Device type
- Heart & Vascular Devices
Timeline
| 17 Apr 2025 | Recall initiated by company | |
| 20 May 2025 | Classified by FDA | +33 days |
| 28 May 2025 | Published 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¿ Single Intragastric Linton Balloon Tube, REF: 0092740
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)00801741076848
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate) recalled | C.R. Bard | Foreign Material | 44 states | |
| CLASS I | Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) recalled | C.R. Bard | Foreign Material | 44 states | |
| CLASS I | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube recalled | C.R. Bard | Foreign Material | 44 states | |
| CLASS I | Bard Blakemore Esophageal-Nasogastric Tube (Adult) recalled by C.R. Bard | C.R. Bard | Foreign Material | 44 states |
More recalls from C.R. Bard
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |