FDA Device recall Z-2050-2016
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 by Circulatory Technology, citing the seal between the balloon and the housing may leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2050-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-03 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Circulatory Technology |
| Distribution | CA, IN, MI, NY, PA, TX, VA |
Product
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Reason
The seal between the balloon and the housing may leak.
Identifiers
| code_info | Lot # 014603 USE BY: 9/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.