FDA Medical Device Recalls (openFDA)
Megadyne Medical Products, Inc: Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE
- Recall number
- Z-0468-03
- Recalling firm
- Megadyne Medical Products, Inc
- Product
- Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE
- Status
- Terminated
- Initiated
- 2002-12-20
- Posted
- 2003-01-30
- Terminated
- 2003-09-05
- Reason
- The metal substrate cautery tip may break during use.
- Root cause
- Other
- Action
- On 12/20/2002, all consignees were notified by letter to return all affected product.
- Quantity
- 19464
- Distribution
- Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.
- Lot, serial or model codes
- Catalog Number 0600. Lots 00664, 00845, 10038, 10190, 10541, 10669, 10703, 10766, 10951, 11110, 11356, 20046, 20219, 20520, 20592, 20757, 20777, 20856, 20997, 21075.
- 510(k) numbers
- ["K943055"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1721194
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28