Z-1451-2013Class II

Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W...

Name: Z-1451-2013 Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W...
Creator: Maytex Corp
Published: 2013-05-15
License: https://open.fda.gov/license/

Maytex Corp / initiated 2013-05-15 / Terminated / root cause: labeling and UDI

FDA source

Maytex Corp began a recall of Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex... on 2013-05-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1451-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Posted: 2013-06-04
Terminated: 2013-10-29
Recalling firm: Maytex Corp
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.
Product code: FXX Mask, Surgical
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm, Maytex Corporation, sent a "MEDICAL DEVICE SAFETY NOTICE" dated May 15, 2013, to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately contact your medical professional for treatment and contact Maytex Corporation to file a complaint should any illness or injury occur; discontinue use of the product if you detect any potential health hazards; if this product has been further sold or distributed, notify your customers to the retail level and send copies of safety notice to customer/users; and complete and promptly return the enclosed Medical Device Safety Notice Return Response Acknowledgement and Receipt form via mail to: Maytex Corporation 23521 Foley Street, Hayward CA 94545; fax at; 510-786-0209; email: [email protected] or by delivery to Maytex Corporation. Maytex Corporation has temporarily taken down their Website at www.maytexcorp.com to correct the wrong product specifications as described in the notice. If you have any questions, contact Maytex Corporation at 1-800-462-9839 or email: [email protected] Monday through Friday, 8:30 AM to 5:00 PM Pacific Time.
Quantity in commerce: 43,915 Cases
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1451-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1451-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-04

Product code FXX

K964358Class IIAmseal Surgical Face MaskAmerican Seal Co. / cleared 1997-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)