FDA Medical Device Recalls (openFDA)
Espiner Medical Ltd: 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.
- Recall number
- Z-0444-2019
- Recalling firm
- Espiner Medical Ltd
- 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.
- Status
- Terminated
- Initiated
- 2018-06-20
- Posted
- not on file
- Terminated
- 2019-12-09
- Reason
- Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
- Root cause
- Error in labeling
- Action
- Espinar Medical notified the distributor to notify accounts to review inventory, product batches should not be used, and should be segregated if deemed necessary by the hospital/healthcare facility. Complete the acknowledgement form. Contact Global Medical Partners LLC via email at cs@globalmedllc.com or by calling 888.384.8490 to obtain an RGA number for the return of the product.
- Quantity
- 230 units
- Distribution
- US Nationwide in the states of CA, IL, MT, NC, NJ,
- Lot, serial or model codes
- Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08
- 510(k) numbers
- ["K111845"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3009231402
- Firm city
- Clevedon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28