ConMed recalls Anchor Tissue Retrieval System (8mm, 125ml) manufactured between April 2018 and February 2019 due to potential sterility compromise. Affected units have specific lot codes.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
ConMed is recalling its Anchor Tissue Retrieval System used in laparoscopic surgery because flaws in the seal could allow contamination. This poses a risk of infection during surgery if the product is not sterile.
The seal in the sterile pouch may have voids or partial seals, creating an open channel that could allow contamination. This could compromise the sterility of the product during surgery, increasing infection risk.
Surgical teams using the ConMed Anchor Tissue Retrieval System for laparoscopic procedures are affected. Patients undergoing surgery with this device are at risk of infection if the product is compromised.
Check the lot code on the product packaging. Units manufactured between April 26, 2018 and February 15, 2019 with specific excluded lot codes (e.g., 20180426X to 20190215X) are affected.
Look for the lot code on the packaging to determine if it falls within the affected range (20180426X to 20190215X, excluding specific listed codes).
The seal may have voids or partial seals, creating an open channel that could compromise sterility and increase infection risk during surgery.
Lot codes from 20180426X to 20190215X, excluding specific codes like 201901244, 201901284, 201901254, and 201901294.
No action is required for unaffected units. Affected units should check the lot code and contact ConMed if needed.
We’ve drafted a message you can send ConMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1308-2019 — ConMed ConMed Hello, I own a ConMed that is covered by recall Z-1308-2019 from ConMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.