Z-0572-03

Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box...

Name: Z-0572-03 Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box...
Creator: Dynarex Corporation
Published: 2002-12-31
License: https://open.fda.gov/license/

Dynarex Corp. / initiated 2002-12-31 / Terminated / root cause: labeling and UDI

FDA source

Dynarex Corporation began a recall of Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation... on 2002-12-31. The reason FDA records is "Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex". 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-0572-03
Status: Terminated
Initiated: 2002-12-31
Posted: 2003-02-25
Terminated: 2012-08-30
Recalling firm: Dynarex Corp.
Product: Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 12 boxes are placed into one shipping carton/case.
Product code: FXX Mask, Surgical
Reason for recall: Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
Root cause tag: labeling and UDI
FDA root cause: Other
Quantity in commerce: 1937 cases (50 masks per box, 12 boxes per case)
Distribution: Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.
Product codes and lots: Reorder No. 2201, Lot Number 14929, Barcode # 16784 22012

Product code FXX

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)