FDA Medical Device Recalls (openFDA)
Megadyne Medical Products, Inc: Rocker Switch Electrosurgical Pencil with E-Z Clean Tip
- Recall number
- Z-0778-06
- Recalling firm
- Megadyne Medical Products, Inc
- Product
- Rocker Switch Electrosurgical Pencil with E-Z Clean Tip
- Status
- Terminated
- Initiated
- 2006-04-06
- Posted
- 2006-04-19
- Terminated
- 2006-08-03
- Reason
- Surgical device packaging may be damaged and may compromise sterility.
- Root cause
- Other
- Action
- Consignees were notified by letter on 04/06/2006.
- Quantity
- 34,132 units
- Distribution
- Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.
- Lot, serial or model codes
- Catalog Number 0030H. Lot numbers: 51269, 51270, 51271, 51272, 51273, 60101, 60102.
- 510(k) numbers
- ["K965054"]
- 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