The Bigger-Better-Bladder — Class II medical device recall Z-2832-2016
Terminated recall by Circulatory Technology Inc, reported 2016-09-21, distributed in LA, MI, NY, OH, OR, TX. The seal between the balloon and the housing may leak.
| Recall number | Z-2832-2016 |
|---|---|
| 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 | 2016-07-01 |
| Classified | 2016-09-15 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2018-06-14 |
| Distributed | LA, MI, NY, OH, OR, TX |
| Quantity | 20 units |
| Reason classes | packaging |
| Lot numbers | 014648 |
| Model numbers | BBB38-72A |
| Expiration dates | 2018-09-01 |
Product
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
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-2832-2016. 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.