Z-0469-03

Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE

Name: Z-0469-03 Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
Creator: Megadyne Medical Products, Inc
Published: 2002-12-20
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2002-12-20 / Terminated

FDA source

Megadyne Medical Products, Inc began a recall of Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE on 2002-12-20. The reason FDA records is "The metal substrate cautery tip may break during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0469-03
Status: Terminated
Initiated: 2002-12-20
Posted: 2003-01-30
Terminated: 2003-09-05
Recalling firm: Megadyne Medical Products, Inc
Product: Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The metal substrate cautery tip may break during use.
FDA root cause: Other
Action: On 12/20/2002, all consignees were notified by letter to return all affected product.
Quantity in commerce: 4855
Distribution: Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.
Product codes and lots: Catalog Number 0600M. Lots 00994, 01880, 01181, 01112, 10156, 10670, 11008, 11388, 20260, 20814.

Product code GEI

K943055Class IIElectrosurgical Cutting and Coagulating Device and AccessoriesMegadyne Medical Products, Inc. / cleared 1994-12-21

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)