The Recall Desk
HighFDA (Devices)·Z-1309-2019·Announced 2019-05-15

ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

Conmed Corporation is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall affects 7,930 units distributed in the US and 13 other countries.

What this means for you

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 infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

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 7,930 units of the 12 MM, 300 ML size (Catalog Number TRS-ROBO-12). The product was distributed nationwide in the United States and in Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, Oman, Poland, Qatar, Romania, Singapore, Spain, and Sweden.

The recall was initiated 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 units were manufactured between April 26, 2018, and February 15, 2019. Specific lot codes are excluded from the recall, including all alpha/numeric lot codes, all numeric lot codes ending in the number 9, and specific numeric codes listed in the agency documentation.

Healthcare facilities and distributors should stop using the affected products and contact Conmed Corporation for further instructions. Consumers are advised to check with their healthcare provider if they have had surgery using this device.

The recalled product

Product
ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 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 duri
Manufacturer
Conmed Corporation
Affected units
7,930

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 (6)

  • Lot codes for product manufactured to and including the dates listed below
  • 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15
  • 201901104
  • 201901144
  • 201901094
  • 201901114

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 →