Z-0498-2008

PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, OASIS...

Name: Z-0498-2008 PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, OASIS...
Creator: Oasis Medical Inc
Published: 2007-07-18
License: https://open.fda.gov/license/

Oasis Medical, Inc. / initiated 2007-07-18 / Terminated / root cause: design

FDA source

Oasis Medical Inc began a recall of PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, OASIS Glendora, CA 91741 on 2007-07-18. The reason FDA records is "Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL". 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-0498-2008
Status: Terminated
Initiated: 2007-07-18
Posted: 2008-01-12
Terminated: 2009-09-25
Recalling firm: Oasis Medical, Inc.
Product: PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, OASIS Glendora, CA 91741
Product code: HNN Knife, Ophthalmic
Reason for recall: Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL
Root cause tag: design
FDA root cause: Device Design
Action: A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.
Quantity in commerce: 28,319 individual knives (Z-0485-0516-2008)
Distribution: Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia
Product codes and lots: Lot No: DK0307O and DK0407K

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)