ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
Conmed Corporation is recalling the Anchor Tissue Retrieval System due to seal defects that may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Conmed Corporation is recalling the ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX), Catalog Number TRS-VATS-15. The recall involves 2,931 units distributed worldwide, including the United States and several international markets.
The recall was initiated because voids in the seal or a partial seal result in an open channel, which may compromise the sterility of the product. The affected units are sterile disposable pouches used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
The recall covers lot codes manufactured between April 26, 2018, and February 15, 2019, with specific exclusions for alpha/numeric lot codes, numeric lot codes ending in 9, and the specific lot code 201808085. Users should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 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…
- Manufacturer
- Conmed Corporation
- Hazard
- Affected units
- 2,931
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot codes for product manufactured to and including the dates listed below
- 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Conmed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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