Z-0996-2007

Premier Edge MVR 20g Microsurgical Knife, Item PE-3520

Name: Z-0996-2007 Premier Edge MVR 20g Microsurgical Knife, Item PE-3520
Creator: Oasis Medical Inc
Published: 2007-06-08
License: https://open.fda.gov/license/

Oasis Medical, Inc. / initiated 2007-06-08 / Terminated / root cause: design

FDA source

Oasis Medical Inc began a recall of Premier Edge MVR 20g Microsurgical Knife, Item PE-3520 on 2007-06-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0996-2007
Status: Terminated
Initiated: 2007-06-08
Posted: 2007-07-04
Terminated: 2009-09-25
Recalling firm: Oasis Medical, Inc.
Product: Premier Edge MVR 20g Microsurgical Knife, Item PE-3520
Product code: HNN Knife, Ophthalmic
Reason for recall: 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 tag: design
FDA 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."
Distribution: Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
Product codes and lots: Lot #'s DK0107AJ, DK0107X, DK0307P

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)