CLASS III ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Halyard Surgical Hood, Universal Size, Blue recalled by O&m Halyard
O&M Halyard is recalling Halyard Surgical Hood, Universal Size, Blue, distributed nationwide in the US. The recall was initiated on 20 Feb 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1461-2024
- FDA event ID
- 94182
- Recalling firm
- O&M Halyard, Mechanicsville, VA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 20 Feb 2024
- FDA classified
- 2 Apr 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 20 Feb 2024 | Recall initiated by company | |
| 2 Apr 2024 | Classified by FDA | +42 days |
| 10 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was mislabeled as a Surgical Cap at its dispenser level.
Product as listed by the FDA
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaHawaiiMinnesotaMissouriMontanaSouth DakotaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Product was mislabeled as a Surgical Cap at its dispenser level.
Which lots are affected?
Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |