[Recalled] FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 — One respirator sample failed a filtration efficiency test | FDA 2023-08-09
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 |
|---|---|
| Brand / manufacturer | O&M HALYARD, INC. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2626-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 August 2023 |
| EAN / barcode | 20680651468271 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.