ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise the sterility of the product.
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 sterile medical device where a seal defect may compromise sterility, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Conmed Corporation is recalling the Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX), Catalog Number TRS175SB2. This sterile disposable pouch is used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
The recall is due to voids in the seal or a partial seal, which results in an open channel and may compromise the sterility of the product. The recall covers 11,835 units distributed worldwide, including the United States (nationwide) and countries such as Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, Oman, Poland, Qatar, Romania, Singapore, Spain, and Sweden.
Affected units include specific lot codes manufactured between April 26, 2018, and February 15, 2019, with certain exclusions for alpha/numeric codes, codes ending in 9, and specific numeric codes listed in the agency documentation. Healthcare providers and facilities should stop using the affected products and contact Conmed Corporation for further instructions.
The recalled product
- Product
- ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 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…
- Manufacturer
- Conmed Corporation
- Affected units
- 11,835
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.
See all 6 products in this recall →Related recalls
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