Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 21, 2018
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.
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Espiner Medical Ltd recalled Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:… - a moderate-severity action.
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:… was recalled by Espiner Medical Ltd in November 21, 2018. Reason: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1…. Check the official notice for the remedy. Verify recall #Z-0444-2019 with the FDA Devices before acting.
The recall
Espiner Medical Ltd issued this moderate-severity FDA Devices recall-Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1….
- Moderate
- severity level
- 230 units
- affected scope
- Class II
- classification
- November 21, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0444-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0444-2019) was formally reported on November 21, 2018, with the manufacturer initiating the action on June 20, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Espiner Medical Ltd is listed as the recalling firm, operating out of Clevedon. Federal records list the affected scope as 230 units.
The documented reason for this recall is: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml Distribution data in the federal record shows the product reached: US Nationwide in the states of CA, IL, MT, NC, NJ,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
230 units
Related Recalls
6
0 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0444-2019 |
| Date reported | November 21, 2018 |
| Date initiated | June 20, 2018 |
| Recalling firm | Espiner Medical Ltd |
| Firm location | Clevedon |
| Affected scope | 230 units |
| Distribution | US Nationwide in the states of CA, IL, MT, NC, NJ, |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0444-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Espiner Medical Ltd. Units affected: 230 units.
Why was this product recalled? ▼
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0444-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of CA, IL, MT, NC, NJ,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0444-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 21, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.