FLUIDSHIELD 3 N95 Mask Filtration Failure (Lot AM2164811)
O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a respiratory protection device where filtration efficiency failed. The failure is in a safety-critical function, but no illnesses or injuries have been reported, making this a risk-of-harm product without reported harm.
Plain-English summary
O&M Halyard is recalling FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT Lining, orange, size small (Product Code 46827). The recall involves 41,790 units with Lot Number AM2164811. One respirator sample failed a filtration efficiency test, indicating the product may not provide adequate protection to users.
The affected masks were distributed throughout the United States to facilities and distributors in Florida, Georgia, Iowa, Illinois, Missouri, Mississippi, Nebraska, Oklahoma, Tennessee, Texas, and Wisconsin. International distribution also reached Colombia.
Consumers, healthcare workers, and facilities with masks from Lot AM2164811 should stop using them immediately and contact O&M Halyard for instructions regarding return or safe disposal. Do not use these masks for respiratory protection.
The recalled product
- Product
- FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
- Manufacturer
- O&M HALYARD, INC.
- Hazard
- filtration-failure
- respiratory-protection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 20680651468271
- Lot Number AM2164811
Distribution
Distributed in 11 states:
- FL
- GA
- IA
- IL
- MO
- MS
- NE
- OK
- TN
- TX
- WI
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