Z-0785-06

Button Switch Electrosurgical Pencil with Holster

Name: Z-0785-06 Button Switch Electrosurgical Pencil with Holster
Creator: Megadyne Medical Products, Inc
Published: 2006-04-06
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2006-04-06 / Terminated / root cause: packaging

FDA source

Megadyne Medical Products, Inc began a recall of Button Switch Electrosurgical Pencil with Holster on 2006-04-06. The reason FDA records is "Surgical device packaging may be damaged and may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0785-06
Status: Terminated
Initiated: 2006-04-06
Posted: 2006-04-19
Terminated: 2006-08-03
Recalling firm: Megadyne Medical Products, Inc
Product: Button Switch Electrosurgical Pencil with Holster
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Surgical device packaging may be damaged and may compromise sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified by letter on 04/06/2006.
Quantity in commerce: 92 units
Distribution: Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.
Product codes and lots: Catalog Number 3035HT. Lot number 51625.

Product code GEI

K965054Class IIPencilMegadyne Medical Products, Inc. / cleared 1997-01-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)