CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
Fluidshield 3 N95 Particulate Filter Respirator recalled by O&m Halyard
O&M Halyard is recalling Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with SO Soft* Lining, distributed in 11 states. The recall was initiated on 9 Aug 2023 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-2626-2023
- FDA event ID
- 92942
- Recalling firm
- O&M Halyard, Mechanicsville, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Aug 2023
- FDA classified
- 21 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 9 Aug 2023 | Recall initiated by company | |
| 21 Sep 2023 | Classified by FDA | +43 days |
| 27 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Where it was distributed
US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
FloridaGeorgiaIowaIllinoisMissouriMississippiNebraskaOklahomaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Which lots are affected?
UDI-DI: 20680651468271; Lot Number AM2164811
Where was it sold?
US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
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.
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 II | Procedure Mask with SO SOFT* Earloops recalled by O&m Halyard | O&M Halyard | Packaging Defects | Nationwide |
Other Surgical Instruments recalls
All 3,903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Square Driver recalled by Think Surgical | Think Surgical | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |