CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Procedure Mask with SO SOFT* Earloops recalled by O&m Halyard
O&M Halyard is recalling Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask, distributed nationwide in the US. The recall was initiated on 8 Nov 2024 and the FDA has classified it as Class II.
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-0728-2025
- FDA event ID
- 95804
- Recalling firm
- O&M Halyard, Mechanicsville, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 8 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +42 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Which lots are affected?
UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 95804| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soft Touch II Surgical Mask, Blue-Disposable surgical mask recalled | O&M Halyard | Packaging Defects | Nationwide |
More recalls from O&M Halyard
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |
| Device | CLASS II | Orthopedic Pack recalled by O&m Halyard | O&M Halyard | Sterility | Nationwide |
| Device | CLASS II | Halyard Laparotomy Pack recalled by O&m Halyard | O&M Halyard | Sterility | Nationwide |
| Device | CLASS II | Soft Touch II Surgical Mask, Blue-Disposable surgical mask recalled | O&M Halyard | Packaging Defects | Nationwide |
| Device | CLASS III | Halyard Surgical Hood, Universal Size, Blue recalled by O&m Halyard | O&M Halyard | Labeling Errors | Nationwide |
Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |