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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65160

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maytex Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1451-2013
Recall number
Z-1451-2013
Initiated
May 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
Maytex Corp
Quantity
43,915 Cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 2/17/10; 003-03, 4/12/10; 002-02 , 3/24/10; 003-03A, 7/23/10; 042-04, 11/29/10; 105-01, 1/31/11; 117-02, 4/29/11; 127/03, 7/8/11; 147-04, 12/16/11; 202-01, 3/8/2012; 224-02, 5/24/2012; 235-03, 9/12/2012; 253-04 , 12//192012

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: 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; and country of: Mexico.