Z-1756-2017Class II

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000...

Name: Z-1756-2017 Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000...
Creator: ConMed Corporation
Published: 2017-02-28
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2017-02-28 / Terminated / root cause: labeling and UDI

FDA source

ConMed Corporation began a recall of Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC... on 2017-02-28. FDA classified it as Class II and gives the reason as "For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1756-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-28
Posted: 2017-04-07
Recalling firm: ConMed Corporation
Product: Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: ConMed sent an URGENT: MEDICAL DEVICE RECALL Notices (dated 2/28/2017)to all affected US customers by USPS First Class Mail. International letters are in the process of translation and are scheduled to be sent by March 15, 2017. Customers were instructed to review their inventory for any of the affected product and were asked to complete the business reply form and return it to ConMed Corporation, 525 French Road, Utica, New York 13502. Customers with questions or requests should contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email [email protected]. For questions regarding this recall call 315-624-3533.
Distribution: Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
Product codes and lots: Serial Numbers: 1540139, 15280024, 15420101, 15470153, 15510179, 16010007, 1540144, 15280026, 15420102, 15470161, 15510182, 16010008, 15250002, 15290032, 15430106, 15490169, 15510186, 16010009, 15250004, 15290033, 15430107, 15490170, 15510189, 16010010, 15250005, 15300038, 15430110, 15490172, 15510190, 16430108, 15250006, 15350041, 15430111, 15500173, 15510192, 16430109, 15250007, 15350043, 15430113, 15500174, 16010001, 16430112, 15250008, 15350044, 15430114, 15500175, 16010002, 15260010, 15360054, 15430115, 15500176, 16010003, 15260012, 15360057, 15460140, 15500177, 16010004, 15260013, 15360059, 15460142, 15510178, 16010005, 15280023, 15360060, 15460146, 15510179, 16010006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1756-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1756-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07
Z-1757-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07
Z-1758-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07
Z-1759-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07
Z-1760-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07

Product code GEI

K963088Class IISheath, Electrosurgical PencilAspen Laboratories, Inc. / cleared 1996-09-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)