Safco Dental Supply Co. Inc. Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
Brand
Safco Dental Supply Co. Inc.
Lot Codes / Batch Numbers
all lots of product code 372-8114 (blue) and 372-8125 (pink)
Products Sold
all lots of product code 372-8114 (blue) and 372-8125 (pink)
Safco Dental Supply Co. Inc. is recalling Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., due to The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026