The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1451-2013·Announced 2013-06-12

Maytex Comfort Ear-Loop Face Masks Recalled for Performance Failures

Maytex Corp is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks because lab testing showed they do not meet stated differential pressure standards and cannot be guaranteed as fluid resistant.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a performance failure (failure to meet pressure and fluid resistance standards) rather than a direct contamination or acute injury risk, fitting the Moderate category for low-risk or precautionary issues without reported harm.

Plain-English summary

Maytex Corporation is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks, Item # 3100. The affected model numbers are # 3100B, # 3100P, # 3100G, # 3100Y, and # 3100W. These masks are intended for basic medical and dental procedures.

The recall was initiated after lab testing conducted in March 2013 indicated that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the packaging. Additionally, the source text states that product manufactured between 2008 and 2012 cannot be guaranteed as Fluid Resistant.

The affected units were distributed worldwide, including nationwide in the United States and in Mexico. Specific U.S. states listed include AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI. The recall covers specific purchase order numbers and receipt dates ranging from February 2008 to December 2012. Consumers and healthcare facilities should stop using the affected masks and contact Maytex Corporation for instructions on return or replacement.

The recalled product

Product
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.
Manufacturer
Maytex Corp
Category
Medical Device — Surgical Masks
Hazard
Affected units
43,915

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All cases of item #: 3100 face mask with PO #. PO #
  • Date of receipt: 809-01
  • 2/5/08
  • 837-02
  • 7/29/08
  • 852-03
  • 10/10/08
  • 901-01
  • 2/3/09
  • 921-02
  • 6/8/09
  • 923-03
  • 7/8/09
  • 926-04
  • 8/26/09
  • 931-05
  • 11/10/09
  • 942-06
  • 12/16/09
  • 001-01

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

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