FDA Device recall Z-1758-2017

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…

FDA Device
Class II
terminated
Published 2017-04-19

On 2017-04-19 the FDA classified a Class II recall of Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car… by Conmed, citing 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 th….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1758-2017
Classification	Class II
Status	terminated
Initiated	2017-02-28
Published	2017-04-19
Last updated	2026-09-13 11:54 UTC
Company	Conmed
Distribution	US

Product

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---

Reason

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.

Identifiers

code_info	Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 1550… Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187, 16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190, 16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193, 16500266, 15400256, 15480435,

code_info

Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 1550…

Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187, 16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190, 16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193, 16500266, 15400256, 15480435,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1758-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.