Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 15, 2019
ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Conmed Corporation recalled ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 … - a moderate-severity action.
ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 … was recalled by Conmed Corporation in May 15, 2019. Reason: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product. Check the official notice for the remedy. Verify recall #Z-1308-2019 with the FDA Devices before acting.
The recall
Conmed Corporation issued this moderate-severity FDA Devices recall-Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product.
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- May 15, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1308-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1308-2019) was formally reported on May 15, 2019, with the manufacturer initiating the action on March 21, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Conmed Corporation is listed as the recalling firm, operating out of Utica, NY. Federal records list the affected scope as 1310.
The documented reason for this recall is: Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.. 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, 6 from FDA Devices - 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
1310
Related Recalls
6
6 from same agency
Product description
ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
Reason for recall
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1308-2019 |
| Date reported | May 15, 2019 |
| Date initiated | March 21, 2019 |
| Recalling firm | Conmed Corporation |
| Firm location | Utica, NY |
| Affected scope | 1310 |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden. |
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-1308-2019) 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? ▼
ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.. Recalled by Conmed Corporation. Units affected: 1310.
Why was this product recalled? ▼
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1308-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1308-2019) 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.
Nearby Recalls in This Category
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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 May 15, 2019. 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 August 2026.