Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Better-Bladder (BB) Recalled by Circulatory Technology Inc. Due to The device is used as part of extracorporeal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Circulatory Technology Inc. directly.
Affected Products
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Quantity: 147 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Circulatory Technology Inc.
Circulatory Technology Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report