Reported Sep 27, 2023 · Ongoing

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product…

O&m Halyard, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: O&M HALYARD, INC. · 9120 Lockwood Blvd · Mechanicsville, VA · 23116-2015

Is this the product you have?

  • FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Lot codes and dates
  • UDI-DI
    • 20680651468271
    • Lot Number AM2164811
Amount recalled
41790 masks

Where it was sold

Why it was recalled

One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.