FDA Medical Device Recalls (openFDA)
Oasis Medical Inc: Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A - Disposable Bimanual Aspiration Handpiece 21g; Item #1721-I Disposable Bimanuals Irrigation/Aspiration Set, 21g, Open End; Item #1721-S Disposable Bimanuals Irrigation/Aspiration Set, 21g, Dual Port, Smooth. For use in cataract surgical procedures.
- Recall number
- Z-0742-2007
- Recalling firm
- Oasis Medical Inc
- Product
- Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A - Disposable Bimanual Aspiration Handpiece 21g; Item #1721-I Disposable Bimanuals Irrigation/Aspiration Set, 21g, Open End; Item #1721-S Disposable Bimanuals Irrigation/Aspiration Set, 21g, Dual Port, Smooth. For use in cataract surgical procedures.
- Status
- Terminated
- Initiated
- 2007-04-09
- Posted
- 2007-06-27
- Terminated
- 2011-10-06
- Reason
- Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.
- Root cause
- Other
- Action
- An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by induding a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."
- Quantity
- 3050 total for all item numbers
- Distribution
- Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
- Lot, serial or model codes
- Item #1721Bimanual Irrigation/Aspiration Set 21 Gauge: DB0105C,DB0105C,DB0605H,DB0705E, DB0804C,DB0804C,DB0905C,DB0906B,DB1104G,DB1104J; ltem #1721-A Disposable Bimanual Aspiration Handpiece 21g: DB1004G; ltem # 1721-I Disposable Bimanual lrrigation Handpiece 21g: DB0105E, DB0105E, DB0705G,DB1004F; Item #1721-S Disp Bimanual I\A Set 21g Dual Port Smooth: DB06051,DB0705F, DB0805B, DB0906A, DB1205B, DB1205D
- 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