The Ebb Complete Tamponade System — Class II medical device recall Z-0123-2016
Terminated recall by Clinical Innovations, LLC, reported 2015-10-21, distributed nationwide. Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 121
| Recall number | Z-0123-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Innovations, LLC, Murray, UT, United States |
| Recall initiated | 2015-01-05 |
| Classified | 2015-10-15 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 827 units |
| Reason classes | packaging |
| Lot numbers | 1214-F-403, 1214-V-424 |
| Model numbers | CTS-1000 |
Product
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Reason for recall
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
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-0123-2016. 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.