Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml… — Class II medical device recall Z-0444-2019
Terminated recall by Espiner Medical Ltd, reported 2018-11-21, distributed nationwide. Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 100
| Recall number | Z-0444-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Espiner Medical Ltd, Clevedon, United Kingdom |
| Recall initiated | 2018-06-20 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2019-12-09 |
| Distributed | Nationwide (US) |
| Quantity | 230 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05060358120367 |
| Lot numbers | 1603, 2020/01, 2020/10, 2022/08, 2022/0L, 2184, A2578, A3162 |
Product
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
Reason for recall
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
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-0444-2019. 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.