Food, drugs, devices › ConMed Corporation

Device recall: ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx O

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products."

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-USA (nationwide) and the countries of China, Dubai and Indonesia."

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 Apr 2017. "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 64248 · Class II · initiated 28 Jan 2013 · status Terminated · terminated 11 Apr 2017

DeviceVoluntary: Firm initiated2 product recordsUtica, NY

FDA enforcement event 64248 is a device recall by ConMed Corporation of Utica, NY, initiated 28 Jan 2013 and classified Class II, with 2 product records.

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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 11 Apr 2017. 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

"Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products."

Distribution

"Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0826-2013	ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.	Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units	Class II	Terminated	27 Feb 2013
Z-0827-2013	ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.	Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units	Class II	Terminated	27 Feb 2013

Context

90%of 2013 device events are Class II1,236 events that year

2product 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
21 Mar 2019	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System	Device	Class II	6
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

All 24 events for ConMed Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products."

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-USA (nationwide) and the countries of China, Dubai and Indonesia."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 Apr 2017. "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.