The Better-Bladder — Class II medical device recall Z-1862-2021
Ongoing recall by Circulatory Technology Inc., reported 2021-06-23, distributed nationwide. The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and m
| Recall number | Z-1862-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Circulatory Technology Inc., Oyster Bay, NY, United States |
| Recall initiated | 2021-04-27 |
| Classified | 2021-06-15 |
| Reported by FDA | 2021-06-23 |
| Distributed | Nationwide (US) |
| Quantity | 147 units |
| UPC / GTIN / UDI-DI | 00851997007004 |
| Lot numbers | 5290-201001 |
| Model numbers | BB14 |
Product
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1862-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.