The Better-Bladder With 14" ID tubing — Class III medical device recall Z-0057-2017
Terminated recall by Circulatory Technology Inc, reported 2016-10-19, distributed nationwide. Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
| Recall number | Z-0057-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Circulatory Technology Inc, Oyster Bay, NY, United States |
| Recall initiated | 2016-07-01 |
| Classified | 2016-10-07 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 958 units |
| Lot numbers | 014601, 014602, 014882, 015323, R19229 |
| Model numbers | BB14 |
Product
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Reason for recall
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
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-0057-2017. 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.