ConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects
ConMed is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall covers 5,034 units distributed worldwide.
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) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Conmed Corporation is recalling the Anchor Tissue Retrieval System, a sterile disposable pouch used during laparoscopic surgery to remove organs or tissue. The recall involves 5,034 units of the 15 MM, 1850 ML (3/BX) catalog number TRS190SB2. The product was distributed nationwide in the United States and in several international countries, including Austria, Canada, Denmark, Great Britain, Ireland, Japan, the Netherlands, Oman, Poland, Qatar, Romania, Singapore, Spain, and Sweden.
The recall is being conducted because voids in the seal or a partial seal can result in an open channel, which may compromise the sterility of the product. The affected lot codes are those manufactured between April 26, 2018, and February 15, 2019, with specific exclusions for alpha/numeric codes, codes ending in 9, and certain listed numeric codes.
Healthcare providers and facilities should stop using the affected products and contact Conmed Corporation for further instructions on returns or replacements. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 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
- 5,034
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 (4)
- Lot codes for product manufactured to and including the dates listed below
- 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15
- 201807275
- 201807175 201807304
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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