Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass 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
**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)
Quantity: 410
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 to 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA
About Circulatory Technology Inc
Circulatory Technology Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report