Z-0944-03

Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co...

Name: Z-0944-03 Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co...
Creator: Safco Dental Supply Co. Inc.
Published: 2003-06-03
License: https://open.fda.gov/license/

Safco Dental Supply LLC / initiated 2003-06-03 / Terminated / root cause: labeling and UDI

FDA source

Safco Dental Supply Co. Inc. began a recall of Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062 on 2003-06-03. The reason FDA records is "The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0944-03
Status: Terminated
Initiated: 2003-06-03
Posted: 2003-06-21
Terminated: 2004-03-24
Recalling firm: Safco Dental Supply LLC
Product: Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
Product code: FXX Mask, Surgical
Reason for recall: The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recalled by letter dated 5/30/03, informing the dentists that the earloop masks were mislabled with the wrong particle filtration efficiency. Correction labels were included with the letter for the dentists to field correct the boxes of masks in their office inventory.
Quantity in commerce: 60,000 boxes
Distribution: Nationwide
Product codes and lots: all lots of product code 372-8114 (blue) and 372-8125 (pink)

Product code FXX

K801036Class IISurgical MaskAmerican Threshold Industries, Inc. / cleared 1980-06-04

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)