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.
What this means for you
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
- mis-labeling
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
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27