FDA Device recall Z-0444-2019
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac ma…
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac ma… by Espiner Medical, citing label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0444-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-20 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Espiner Medical |
| Distribution | US |
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
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Identifiers
| code_info | Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08 |
|---|
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-0444-2019%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.