FDA Medical Device Recalls (openFDA)
BD Opthalmic Systems: BD K-3000 Microkeratome Blade REF 378607
- Recall number
- Z-0634-03
- Recalling firm
- BD Opthalmic Systems
- Product
- BD K-3000 Microkeratome Blade REF 378607
- Status
- Terminated
- Initiated
- 2003-01-24
- Posted
- 2003-03-12
- Terminated
- 2003-04-28
- Reason
- Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
- Root cause
- Other
- Action
- BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form.
- Quantity
- 1539 Blades
- Distribution
- Nationwide
- Lot, serial or model codes
- Manufacturing Lot Numbers: 959, 962, 964, 965, and 966
- 510(k) numbers
- ["K022637"]
- PMA numbers
- not on file
- Product code
- HMY
- Firm FEI
- not on file
- 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