Z-0154-2008

Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320...

Name: Z-0154-2008 Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320...
Creator: Precept Medical Products, Inc.
Published: 2007-09-14
License: https://open.fda.gov/license/

Precept Medical Products, Inc. / initiated 2007-09-14 / Terminated / root cause: manufacturing process

FDA source

Precept Medical Products, Inc. began a recall of Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box, 6 box/case, Precept Medical Products... on 2007-09-14. The reason FDA records is "Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0154-2008
Status: Terminated
Initiated: 2007-09-14
Posted: 2007-12-28
Terminated: 2009-09-11
Recalling firm: Precept Medical Products, Inc.
Product: Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box, 6 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico
Product code: FYA Gown, Surgical
Reason for recall: Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified its consignees on 09/14/2007 by Urgent Voluntary Medical Device Recall letter (USPS mail, certified, return-receipt requested). The recall was expanded on 10/04/2007 by Urgent Voluntary Medical Device Recall--Expansion Letter to include additional lots of product. Recall letters instruct users to cease use of devices and return them as well as conduct sub-recalls to the users level for any devices they have sub-distributed.
Quantity in commerce: 11,546,350 (both products-Z-0153/0154-2008)
Distribution: Worldwide; USA, Australia and Canada
Product codes and lots: Lot Numbers: 1060800 through 1060890, 1060170, 1060180, 1060190, 1060200, 1060230, 1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060330, 1060340, 1060380, 1060390, 1060400, 1060410, 1060440, 1060450, 1060460, 1060470, 1060510, 1060520, 1060530, 1060540, 1060580, 1060590, 1060600, 1060610, 1060620, 1060650, 1060660, 1060670, 1060680, 1061170, 1061530, 1061560, 1061720, 1071730, 1061790, 1061880, 1061990, 1062000, 1062010, 1062070, 1062080, 1062230, 1062260, 1062270, 1062400, 1062410, 1062420, 1062470, 1062480, 1062540, 1062550, 1062560, 1062620, 1062630, 1062680, 1062690, 1062700, 1062760, 1063310, 1063320, 1063330, 1063340, 1063380, 1063390, 1070250, 1070260, 1070270, 1070330, 1070340, 1070360, 1070370, 1071370, 1071380, 1071420, 1071520, 1071590, 1071870, 1072010, 1072090, 1072140, 1072150, 1072180, 1072210, 1072220, 1072290, 1072300, 1072370, 1072390, 1072580

Product code FYA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)