FDA Medical Device Recalls (openFDA)
Dynarex Corporation: Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. 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 4 boxes are placed into one shipping carton/case.
- Recall number
- Z-0573-03
- Recalling firm
- Dynarex Corporation
- Product
- Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. 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 4 boxes are placed into one shipping carton/case.
- Status
- Terminated
- Initiated
- 2002-12-31
- Posted
- 2003-02-25
- Terminated
- 2012-08-30
- Reason
- Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
- Root cause
- Other
- Action
- not on file
- Quantity
- 396 cases (50 masks per box, 4 boxes per case)
- Distribution
- Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.
- Lot, serial or model codes
- Reorder No. 2202, Lot Number 14929, Barcode # 16784 22023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FXX
- Firm FEI
- 2431014
- Firm city
- Orangeburg
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28