Comfort brand Ear-Loop Face Mask — Class II medical device recall Z-1451-2013
Terminated recall by Maytex Corp, reported 2013-06-12, distributed nationwide. Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Different
| Recall number | Z-1451-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maytex Corp, Hayward, CA, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-06-04 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2013-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 43,915 cases |
| Model numbers | 3100, 3100B, 3100G, 3100P, 3100W, 3100Y |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1451-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.