FDASeptember 22, 2017device
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
What to do
FDA enforcement status: Terminated
Brands named
circulatory technologycirculatory
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCCombination Smoke and Carbon Monoxide (CO) Detectors Recalled Due to Risk of Serious Injury or Death from Failure to Alert Consumers to Fire; Sold Exclusively on Amazon.com by Treatlife Technology2026-06-25
- CPSCLuminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn2026-05-28
- CPSCSuperbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop2026-05-14
- CPSCTiyol Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Sold on Amazon by ZW Creations2026-05-14
- CPSCLithium Coin Batteries Recalled Due?to Risk of Serious Injury or Death from Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Coin Batteries; Imported and Sold on Amazon by LiCB2026-05-14
- CPSCEarthtec Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Tonyidea2026-04-30
- CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
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