FDA Medical Device Recalls (openFDA)
BD Opthalmic Systems: BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240
- Recall number
- Z-1344-04
- Recalling firm
- BD Opthalmic Systems
- Product
- BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240
- Status
- Terminated
- Initiated
- 2004-09-16
- Posted
- 2004-08-14
- Terminated
- 2005-02-17
- Reason
- Blade may become detached from the handle
- Root cause
- Other
- Action
- BD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement product.
- Quantity
- 6945 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 3182770, 3231212, 3234243, 3238890, 3274064, 3281592, 3318026, 3325843, 3330607, 3344597, 3344633, 4012982, 4033079, 4049076, 4069650, 4084089, 4084102, 4106845, 4125046, 4141947, 4147817
- 510(k) numbers
- ["K820618"]
- PMA numbers
- not on file
- Product code
- HNN
- 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