Z-0587-06

Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot...

Name: Z-0587-06 Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot...
Creator: Inovel LLC
Published: 2006-02-20
License: https://open.fda.gov/license/

Moldex/Metric, Inc. / initiated 2006-02-20 / Terminated / root cause: labeling and UDI

FDA source

Inovel LLC began a recall of Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161 on 2006-02-20. The reason FDA records is "Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number". 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-0587-06
Status: Terminated
Initiated: 2006-02-20
Posted: 2006-03-03
Terminated: 2007-01-29
Recalling firm: Moldex/Metric, Inc.
Product: Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
Product code: MSH Respirator, Surgical
Reason for recall: Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recalling process will be initiated by 2/22/06. Distributors will be notified of the recall through a certified recall letter and they will in turn notify and recall product from their customers and return all affected product to Inovel.
Quantity in commerce: 40 cases ( 6, 400 respirators )
Distribution: Nationwide (CA, FL, ME, NY, OH, WI)
Product codes and lots: Lot Number 051130-161

Product code MSH

K051182Class IIInovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC / cleared 2005-05-19

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)