FDA Medical Device Recalls (openFDA)
Safco Dental Supply Co. Inc.: Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
- Recall number
- Z-0944-03
- Recalling firm
- Safco Dental Supply Co. Inc.
- Product
- Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
- Status
- Terminated
- Initiated
- 2003-06-03
- Posted
- 2003-06-21
- Terminated
- 2004-03-24
- Reason
- The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
- 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
- 60,000 boxes
- Distribution
- Nationwide
- Lot, serial or model codes
- all lots of product code 372-8114 (blue) and 372-8125 (pink)
- 510(k) numbers
- ["K801036"]
- PMA numbers
- not on file
- Product code
- FXX
- Firm FEI
- 1416277
- Firm city
- Northbrook
- Firm state
- IL
- 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