Mask, Surgical
FDA adverse event reports and recall history for mask, surgical (product code FXX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 527
- Deaths
- 0
- Injuries
- 257
- Malfunctions
- 181
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-12-20Open, ClassifiedNonconforming Material/Component
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
- 2024-12-20Open, ClassifiedNonconforming Material/Component
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
- 2024-02-16Open, ClassifiedUnder Investigation by firm
HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 2024-02-16Open, ClassifiedUnder Investigation by firm
HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 2024-02-16Open, ClassifiedUnder Investigation by firm
PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 2023-02-03Open, ClassifiedLabeling Change Control
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
- 2013-06-04TerminatedLabeling False and Misleading
Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.
- 2003-06-21TerminatedOther
Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
- 2003-02-25TerminatedOther
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 labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
- 2003-02-25TerminatedOther
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.
Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
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