# FDA recall Z-0444-2019

> **Espiner Medical Ltd** · Class II · device recall initiated 2018-06-20.

## 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

## Distribution

US Nationwide in the states of CA, IL, MT, NC, NJ,

## Key facts

- **Recall number:** Z-0444-2019
- **Recalling firm:** Espiner Medical Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-20
- **Report date:** 2018-11-21
- **Termination date:** 2019-12-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clevedon, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2019

## Citation

> AI Analytics. FDA recall Z-0444-2019. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0444-2019. Source: US FDA. Licensed CC0.

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