“O&M HALY: Fluidshield 3 N95 Mask May Not Provide Adequate Protection.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57511-o-m-haly-fluidshield-3-n95-mask-may-not-provide. Based on FDA recall #Z-2626-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2626-2023%22&limit=1).
The FDA announced on August 9, 2023, that O&M HALYARD is recalling FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Masks because one sample failed a filtration efficiency test. Owners should stop using the product immediately.
How to tell if you have it
Brand: O&M HALYARD
Product: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small
Product Code: 46827
UDI-DI: 20680651468271
Lot Number: AM2164811
The hazard
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Context
GovInfoNow's records show O&M HALYARD INC has had six other recalls since September 27, 2021. Recent recalls include Halyard Purezero Ultraviolet Nitrile Exam Gloves on April 13, 2026, and an Orthopedic Pack recall on July 17, 2025. Other recent recalls of similar products include New York Embroidery Studio Trinity Non-Surgical Isolation Gown (July 31, 2026) and Medline Oxygen Masks (November 21, 2025).
How to tell if you have this one
Check for the orange color, size small, and the product code 46827 on the mask. The UDI-DI number 20680651468271 and lot number AM2164811 are also on the mask.
Brand
O&M HALYARD
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the recalled Fluidshield 3 N95 mask with soft lining (orange, size small).
Where it went and when
Where it was distributed
Distributed in 11 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2626-2023 (August 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2626-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.