Halyard surgical hood mislabeled as surgical cap at dispenser
O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a minor labeling error where the product dispenser is mislabeled. No illnesses or injuries have been reported, and the hazard is limited to product misidentification rather than a physical safety risk.
Plain-English summary
O&M Halyard, Inc. is recalling HALYARD SURGICAL HOOD (Model No. 69110, Universal Size, Blue, 300 count). This recall affects approximately 250 cases containing 75,000 pieces.
The product was mislabeled as a Surgical Cap at its dispenser level. The dispenser label incorrectly identifies this product as a surgical cap rather than a surgical hood.
The affected product was distributed worldwide, including U.S. nationwide distribution in Arizona, California, Colorado, Florida, Hawaii, Minnesota, Missouri, Montana, South Dakota, Tennessee, Texas, and Washington, as well as Canada.
The recalled product
- Product
- HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
- Manufacturer
- O&M HALYARD, INC.
- Hazard
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 (3)
- Model No. 69110
- UDI-DI: 20680651691105
- Lot No. CG22292XXX.
Distribution
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