Z-1461-2024Class III

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

Name: Z-1461-2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Creator: O&m Halyard, Inc.
Published: 2024-02-20
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2024-02-20 / Open, Classified / root cause: labeling and UDI

FDA source

O&M HALYARD, INC. began a recall of HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) on 2024-02-20. FDA classified it as Class III and gives the reason as "Product was mislabeled as a Surgical Cap at its dispenser level". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1461-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-02-20
Posted: 2024-04-02
Recalling firm: O&M Halyard, Inc.
Product: HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product code: FXY Hood, Surgical
Reason for recall: Product was mislabeled as a Surgical Cap at its dispenser level.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 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.
Product codes and lots: Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-02

Product code FXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)