FDA Medical Device Recalls (openFDA)
Oasis Medical Inc: OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).
- Recall number
- Z-1595-05
- Recalling firm
- Oasis Medical Inc
- Product
- OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).
- 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. The firm has taken action; but, due to administrative issues additional products are 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 4036V Lot D1201AD Lot D0702A Y Lot D0802J Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y Lot D0805A8
- 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