HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x… recallZ-1461-2024 · O&M Halyard, Inc. · initiated Feb 20, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from O&M Halyard, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was mislabeled as a Surgical Cap at its dispenser level.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1461-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2024
- Posted by the FDA
- Apr 2, 2024
- Recalling firm
- O&M Halyard, Inc.
- Quantity
- 250 cases (75,000 pieces)
- Product code
- FXY
- 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.
Product description
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Code information (models, lots, serial numbers)
Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard 69110O&M Halyard, Inc. · CAP, SURGICAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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