The National Institute for Occupational Safety and Health (NIOSH) has announced the voluntary rescission of respirator approvals for several models at the request of the manufacturers.
Kimberly-Clark Corporation has requested the rescission of four NIOSH-approved respirators, including several popular duckbill-style models.
Additionally, ivWatch, LLC has requested the rescission of one approved respirator. As a result of these requests, the affected respirators are no longer NIOSH-approved and may not be manufactured, assembled, sold, distributed, or used in any occupational setting that requires NIOSH-approved protection.
Affected Kimberly-Clark Models
Effective June 9, 2025, the rescinded approvals apply to the following item numbers, which include the FluidShield and PFR95 models in both regular and small sizes, as well as a white duckbill model:
- 46827
- 46828
- 46867
- 46727
- 46728
- 46767
- 62355
- 62126
These models previously carried NIOSH approval but are no longer authorized for use under that designation.
What This Means
Facilities and individuals must immediately discontinue use of any respirators bearing the affected NIOSH approval numbers. This also applies to any stock in inventory, including items still in original packaging. These products can no longer be legally:
- Manufactured
- Assembled
- Sold or resold
- Distributed
- Worn in NIOSH-compliant settings
Important Manufacturer Packaging Notice: Kimberly-Clark vs. O&M Halyard
It’s important to verify the manufacturer name, not just the item number or style, because different manufacturers—such as Kimberly-Clark and O&M Halyard—may produce visually similar respirators with identical item numbers, but only products from manufacturers with current NIOSH approval are authorized for use in healthcare and other regulated settings.
For example, the item number, style, and illustration on the product manufactured by Kimberly-Clark (now rescinded) are the same as those made by O&M Halyard (still approved).