Lower riskMedical device recall · FDA · Published February 20, 2024
O&M HALYARD Surgical Hood Recall: Mislabeling as Surgical Cap
O&M HALYARD recalls 300-count blue surgical hood (model 69110) mislabeled as surgical cap. Affected units sold in 2022-2023; no safety risk but may cause confusion.
“O&M HALYARD Surgical Hood Recall: Mislabeling as Surgical Cap.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56132-o-m-halyard-surgical-hood-recall-mislabeling-as-surgical-cap. Based on FDA recall #Z-1461-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2024%22&limit=1).
O&M HALYARD INC recalled HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) because it was mislabeled as a Surgical Cap at its dispenser level, the FDA said on Feb. 20, 2024.
How to tell if you have it
O&M HALYARD
HALYARD SURGICAL HOOD
Model No. 69110
UDI-DI: 20680651691105
Lot No. CG22292XXX
The hazard
The product was mislabeled as a Surgical Cap at its dispenser level, according to the FDA.
Context
GovInfoNow's records show O&M HALYARD INC has had six other recalls since Sept. 27, 2021, including a chemical permeation failure in nitrile exam gloves on April 13, 2026, and open seals in orthopedic packs on July 17, 2025. Other recent recalls of similar products include Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025) and AVID Medical Halyard Arteriogram Recall (Nov. 14, 2025).
How to tell if you have this one
Check for the blue surgical hood (300 count, model 69110) with UDI-DI: 20680651691105 and lot number CG22292XXX. The product was sold between 2022 and 2023.
Brand
O&M HALYARD
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number 69110 and lot number CG22292XXX on the product.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Hawaii, Minnesota, Missouri, Montana, South Dakota, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1461-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1461-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.