FDA Medical Device Recalls (openFDA)
Inovel LLC: Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
- Recall number
- Z-0587-06
- Recalling firm
- Inovel LLC
- Product
- Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
- Status
- Terminated
- Initiated
- 2006-02-20
- Posted
- 2006-03-03
- Terminated
- 2007-01-29
- Reason
- 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
- 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
- 40 cases ( 6, 400 respirators )
- Distribution
- Nationwide (CA, FL, ME, NY, OH, WI)
- Lot, serial or model codes
- Lot Number 051130-161
- 510(k) numbers
- ["K051182"]
- PMA numbers
- not on file
- Product code
- MSH
- Firm FEI
- 1000098753
- Firm city
- Culver City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28