FDA Medical Device Recalls (openFDA)
Inovel LLC: Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
- Recall number
- Z-1576-2009
- Recalling firm
- Inovel LLC
- Product
- Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
- Status
- Terminated
- Initiated
- 2008-07-23
- Posted
- 2009-07-13
- Terminated
- 2009-07-17
- Reason
- 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
- 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
- 80 cases
- Distribution
- US (Illinois only).
- Lot, serial or model codes
- Lot Number: 060713-244.
- 510(k) numbers
- ["K042267"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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