Bigger-Better-Bladder With 3/8" ID tubing — Class II medical device recall Z-2050-2016
Terminated recall by Circulatory Technology Inc, reported 2016-07-06, distributed in CA, IN, MI, NY, PA, TX, VA. The seal between the balloon and the housing may leak.
| Recall number | Z-2050-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Circulatory Technology Inc, Oyster Bay, NY, United States |
| Recall initiated | 2016-03-03 |
| Classified | 2016-06-27 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-04-20 |
| Distributed | CA, IN, MI, NY, PA, TX, VA |
| Quantity | 72 units |
| Reason classes | packaging |
| Lot numbers | 014603 |
| Model numbers | BBB38 |
| Expiration dates | 2018-09 |
Product
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Reason for recall
The seal between the balloon and the housing may leak.
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-2050-2016. 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.