O & M HALYARD, INC. HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Brand
O & M HALYARD, INC.
Lot Codes / Batch Numbers
Model No. 69110, UDI-DI: 20680651691105, Lot No. CG22292XXX.
Products Sold
Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
O & M HALYARD, INC. is recalling HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) due to Product was mislabeled as a Surgical Cap at its dispenser level.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was mislabeled as a Surgical Cap at its dispenser level.
Recommended Action
Per FDA guidance
Consignees were sent an URGENT: MEDICAL DEVICE FIELD ACTION notification via email, dated 2/20/24. The notification instructs consignees to immediately discontinue use of affected devices and discard. End users are to contact their distributor/sales representative with any questions they may have. Distributors are to discard any product in stock, notify their consignees that further received product, and maintain records of effectiveness. Field Action Response Forms are to be completed and returned to the firm at GM-RECALLNOTIFICATION@owens-minor.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026