Z-0767-2007

Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged...

Name: Z-0767-2007 Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged...
Creator: Miltex, Inc.
Published: 2007-04-09
License: https://open.fda.gov/license/

Miltex, Inc. / initiated 2007-04-09 / Terminated / root cause: packaging

FDA source

Miltex, Inc. began a recall of Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels on 2007-04-09. The reason FDA records is "Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0767-2007
Status: Terminated
Initiated: 2007-04-09
Posted: 2007-04-21
Terminated: 2007-08-07
Recalling firm: Miltex, Inc.
Product: Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.
Product code: GES Blade, Scalpel
Reason for recall: Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall.
Quantity in commerce: 400 boxes
Distribution: Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA.
Product codes and lots: Part number 4-422, Lot number S07A10

Product code GES

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)