Z-1576-2009

Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010

Name: Z-1576-2009 Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010
Creator: Inovel LLC
Published: 2008-07-23
License: https://open.fda.gov/license/

Moldex/Metric, Inc. / initiated 2008-07-23 / Terminated / root cause: packaging

FDA source

Inovel LLC began a recall of Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010 on 2008-07-23. The reason FDA records is "Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1576-2009
Status: Terminated
Initiated: 2008-07-23
Posted: 2009-07-13
Terminated: 2009-07-17
Recalling firm: Moldex/Metric, Inc.
Product: Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
Product code: MSH Respirator, Surgical
Reason for recall: Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The recalling process was initiated on July 23, 2007. The affected distributor was notified of the recall through a certified recall letter with an attached Customer Response card. The distributor was instructed to notify and obtain recall product from their customers and return all affected product to Inovel. Direct questions about the recall to Inovel at 1-866-546-6835.
Quantity in commerce: 80 cases
Distribution: US (Illinois only).
Product codes and lots: Lot Number: 060713-244.

Product code MSH

K042267Class IIInovel Health Care N95 Particulate Respirator and Surgical Mask, Models 3001N95-S, 3002N95-M, 3003N95-L, and 3004N95-LpInovel, LLC / cleared 2004-09-30

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)