Food, drugs, devices › Conmed Corporation

Device recall: ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product"

Q: What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden."

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 82478 · Class II · initiated 21 Mar 2019 · status Terminated · terminated 17 Jan 2023

DeviceVoluntary: Firm initiated6 product recordsUtica, NY

Conmed Corporation (Utica, NY) initiated this device recall on 21 Mar 2019; FDA lists 6 product records under event 82478, classified Class II.

FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 17 Jan 2023. Initiation: voluntary: firm initiated. Conmed Corporation has 24 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Conmed Corporation, Utica, NY.

Reason for recall

"Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product"

Distribution

"Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1304-2019	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 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 laparoscopic surgery.	69385	Class II	Terminated	15 May 2019
Z-1305-2019	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 laparoscopic surgery.	11835	Class II	Terminated	15 May 2019
Z-1306-2019	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 laparoscopic surgery.	5034	Class II	Terminated	15 May 2019
Z-1307-2019	ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 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 laparoscopic surgery.	2931	Class II	Terminated	15 May 2019
Z-1308-2019	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 laparoscopic surgery.	1310	Class II	Terminated	15 May 2019
Z-1309-2019	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 during laparoscopic surgery.	7930	Class II	Terminated	15 May 2019

Context

88%of 2019 device events are Class II968 events that year

6product records in this eventfirm median: 2

24events on this register for the firm

Other enforcement events for Conmed Corporation

Initiated	Product (first record)	Type	Class	Records
14 Jul 2026	CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor	Device	Class II	1
14 May 2026	ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units pe	Device	Class II	11
18 Nov 2022	Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187	Device	Class II	1
26 Mar 2021	INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 a	Device	Class II	2
12 Nov 2020	Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.	Device	Class II	2
23 Feb 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use i	Device	Class II	5
19 Jun 2017	STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numb	Device	Class II	2
17 Apr 2017	Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be use	Device	Class II	1
28 Feb 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurg	Device	Class II	5
29 Aug 2016	CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The Heat	Device	Class II	1

All 24 events for Conmed Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.