ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
Conmed Corporation is recalling specific lots of the Anchor Tissue Retrieval System because seal defects may compromise the product's 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 sterile medical device where a seal defect compromises sterility, creating a risk of infection. This fits the 'High' severity criteria 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 affects 1,310 units of the 8 MM, 125 ML size (Catalog Number TRS-ROBO-8) manufactured between April 26, 2018, and February 15, 2019.
The recall was initiated because voids in the seal or a partial seal can create an open channel, which may compromise the sterility of the product. This defect poses a risk of infection if the non-sterile product is used in a surgical procedure.
The affected products were distributed nationwide in the United States and in several international countries, including Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, Oman, Poland, Qatar, Romania, Singapore, Spain, and Sweden. Healthcare facilities and distributors should stop using the affected lots and contact Conmed Corporation for instructions on return or replacement.
The recalled product
- Product
- ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 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
- 1,310
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 (5)
- Lot codes for product manufactured to and including the dates listed below
- 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15
- 201901284
- 201901254
- 201901294
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
Same manufacturer · Conmed Corporation
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- HighConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateConMed Recalls Nonabsorbable Suture Anchor System Due to Manufacturing Error
FDA (Devices) · 2017-12-20
- HighConMed Recalls TUR Endoscopic Cables Due to Compromised Sterile Pouch Seals
FDA (Devices) · 2013-01-30
- HighConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30
- ModerateConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30
- HighConMed Recalls UltraClean Accessory Electrode Blades Due to Seal Compromise
FDA (Devices) · 2013-01-30
- ModerateConMed Recalls Electrosurgical Safety Holsters Due to Compromised Sterile Seals
FDA (Devices) · 2013-01-30