FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15 Degree, REF DP8415, 6 needles per pouch, nonsterile.
- Recall number
- Z-2047-2008
- Recalling firm
- Bausch & Lomb Inc
- Product
- Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15 Degree, REF DP8415, 6 needles per pouch, nonsterile.
- Status
- Terminated
- Initiated
- 2008-03-26
- Posted
- 2008-09-16
- Terminated
- 2010-01-21
- Reason
- The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Root cause
- Labeling Change Control
- Action
- The recalling firm issued letters dated 3/26/08 through a contracted recall notification company who issued the letters via UPS return receipt. A confirmation form was enclosed which was to be completed and returned. If you have questions, contact Customer Service at 1-800-338-2020.
- Quantity
- Total of all sizes - 4,055/6-needle packages
- Distribution
- Distribution was made nationwide direct to medical facilities, which included some government accounts. Foreign distribution was made to Australia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, England, France, Germany, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon.,The Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Thailand, Turkey, and United Arab Emerites.
- Lot, serial or model codes
- Lot numbers 3168902, 3171340, 3172112, 3172321, 3172885
- 510(k) numbers
- ["K041998"]
- PMA numbers
- not on file
- Product code
- NKX
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- 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