CLASS II ONGOING Device recall · Reported 3 Jun 2026 · FDA Enforcement Report
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled
O&M Halyard is recalling Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772, distributed nationwide in the US. The recall was initiated on 13 Apr 2026 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-2230-2026
- FDA event ID
- 98805
- Recalling firm
- O&M Halyard, Alpharetta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Apr 2026
- FDA classified
- 22 May 2026
- Reported
- 3 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 13 Apr 2026 | Recall initiated by company | |
| 22 May 2026 | Classified by FDA | +39 days |
| 3 Jun 2026 | 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
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Product as listed by the FDA
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Where it was distributed
US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Nationwide CaliforniaGeorgiaMassachusettsNorth CarolinaNew JerseyNew York
Questions about this recall
Why was it recalled?
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Which lots are affected?
REF: 48771/UDI: 30680651487712 (Package)20680651487715 (Primary)90680651487714 (Unit of Use) ; 48772/30680651487729 (Package)20680651487722 (Primary)90680651487721 (Unit of Use);48773/30680651487736 (Package)20680651487739 (Primary)90680651487738 (Unit of Use);48774/UDI: 30680651487743 (Package)20680651487746 (Primary) 90680651487745 (Unit of Use);48775/UDI:30680651487750 (Package)20680651487753 (Primary)90680651487752 (Unit of Use)
Where was it sold?
US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
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.
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