Z-0826-2013Class II

ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips...

Name: Z-0826-2013 ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips...
Creator: ConMed Corporation
Published: 2013-01-28
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2013-01-28 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA... on 2013-01-28. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0826-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Posted: 2013-02-15
Terminated: 2017-04-11
Recalling firm: ConMed Corporation
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.
Quantity in commerce: Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
Product codes and lots: Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0826-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0826-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15
Z-0827-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15

Product code GEI

K800617Class IIHyfrecator, #733Birtcher Corp. / cleared 1980-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)