Exact FDA event identifier

Event 81003

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: June 20, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Espiner Medical Ltd

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0444-2019

Recall number: Z-0444-2019
Initiated: June 20, 2018
Classification: Class II
Status: Terminated
Recalling firm: Espiner Medical Ltd
Quantity: 230 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Label was incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml

Code information

Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08

Distribution pattern

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