FDAClass IIIApril 10, 2024

Halyard Surgical Hood recall: Labeling Error

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

Why was Halyard Surgical Hood recalled?

Product was mislabeled as a Surgical Cap at its dispenser level.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.

Product
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Recalling firm
O&M HALYARD, INC.
Quantity
250 cases (75,000 pieces)
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.
Recall date
April 10, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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