Exact FDA event identifier

Event 94182

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 20, 2024
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: O&M HALYARD, INC.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1461-2024

Recall number: Z-1461-2024
Initiated: February 20, 2024
Classification: Class III
Status: Ongoing
Recalling firm: O&M HALYARD, INC.
Quantity: 250 cases (75,000 pieces)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.