Circulatory Technology Bigger Better-Bladder Reservoir Recall: Risk of Blood Flow Drop
Circulatory Technology recalls Bigger Better-Bladder cardiopulmonary bypass blood reservoirs (BBB38 and BBB38NS) due to potential collapse during use, which may cause reduced blood flow in ECMO circuits.
Stop using this now
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.
Contact the company
What happened, in plain English
Circulatory Technology is recalling specific blood reservoir models used in ECMO treatments because they can collapse during use, potentially reducing blood flow in life-support systems. This is serious for patients relying on these devices. Read more at govinfonow.com/recall/72958-circulatory-technology-bigger-better-bladder-reservoir-recall-risk-of-blood.
Source Summary by GovInfoNow · govinfonow.com/recall/72958-circulatory-technology-bigger-better-bladder-reservoir-recall-risk-of-blood · Updated September 17, 2026 · FDA enforcement record: FDA #Z-1171-2018
Cite this page
“Circulatory Technology Bigger Better-Bladder Reservoir Recall: Risk of Blood Flow Drop.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72958-circulatory-technology-bigger-better-bladder-reservoir-recall-risk-of-blood. Based on FDA recall #Z-1171-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1171-2018%22&limit=1).
Why it’s dangerous
The reservoirs can collapse during use in ECMO circuits, increasing resistance in the venous line. This may cause a drop in blood flow, which is critical for patients on life support.
Who’s affected
Patients using ECMO treatments with these reservoir models are at risk. Healthcare providers who use the recalled products should check their equipment.
How to tell if you have this one
Check for model numbers BBB38 (individual, sterile, pouched) or BBB38NS (sold in bulk to kit manufacturers). The recall includes specific lot numbers: 5300-S19813 for BBB38 and 1707-1 and 170903 for BBB38NS.
- Brand
Circulatory Technology- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
**Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0817-2018 | Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers); **Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905 | 840 |
| Z-1171-2018 | **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); **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903 | 410 |
What to do — step by step
Stop Using Now
Immediately stop using the recalled reservoirs as they can collapse during ECMO treatment, causing reduced blood flow.
Where it went and when
Where it was distributed
Distributed in 19 states and D.C..
FDA distribution: “**Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arkansas, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1171-2018 (September 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1171-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.