FDA Medical Device Recalls (openFDA)
Becton Dickinson and Company: BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
- Recall number
- Z-0066-2008
- Recalling firm
- Becton Dickinson and Company
- Product
- BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
- Status
- Terminated
- Initiated
- 2007-08-09
- Posted
- 2007-10-23
- Terminated
- 2012-02-29
- Reason
- Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea
- Root cause
- Component design/selection
- Action
- BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.
- Quantity
- 256 units
- Distribution
- Worldwide
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K023092"]
- PMA numbers
- not on file
- Product code
- HMY
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- 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