Z-0486-2010

E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020...

Name: Z-0486-2010 E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020...
Creator: Megadyne Medical Products, Inc.
Published: 2009-10-13
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2009-10-13 / Terminated / root cause: labeling and UDI

FDA source

Megadyne Medical Products, Inc. began a recall of E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY... on 2009-10-13. The reason FDA records is "Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07". 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-0486-2010
Status: Terminated
Initiated: 2009-10-13
Posted: 2009-12-03
Terminated: 2010-02-17
Recalling firm: Megadyne Medical Products, Inc
Product: E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions.
Quantity in commerce: 324 units
Distribution: Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.
Product codes and lots: Lot Number: 91469.

Product code GEI

K081791Class IIE-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc. / cleared 2008-10-21

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)