FDA Medical Device Recalls (openFDA)
Oasis Medical Inc: OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.
- Recall number
- Z-1599-05
- Recalling firm
- Oasis Medical Inc
- Product
- OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.
- Status
- Terminated
- Initiated
- 2005-08-24
- Posted
- 2005-10-01
- Terminated
- 2014-03-24
- Reason
- "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators
- Root cause
- Other
- Action
- OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.
- Quantity
- 9,859 cannulas for all codes
- Distribution
- Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
- Lot, serial or model codes
- Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYG
- Firm FEI
- 2083373
- Firm city
- Glendora
- Firm state
- CA
- 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