FDA Medical Device Recalls (openFDA)
Oasis Medical Inc: Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A
- Recall number
- Z-0997-2007
- Recalling firm
- Oasis Medical Inc
- Product
- Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A
- Status
- Terminated
- Initiated
- 2007-06-08
- Posted
- 2007-07-04
- Terminated
- 2009-09-25
- Reason
- This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.
- Root cause
- Device Design
- Action
- Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user 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 ofthis product recall. Your notification to your customers may be enhanced by including 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
- not on file
- Distribution
- Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
- Lot, serial or model codes
- Lot #'s DK0107Y, DK0307D, DK0307Q, DK1206M
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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