FDA DevicesClass II
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS),...
Published: June 3, 2026Recall ID: Z-2230-2026Category: devicesCountry: US
Reason for Recall / Hazard
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Product Description & Identification
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Affected Products
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Additional Source Details
| Field | Value |
|---|---|
| City | Alpharetta |
| State | GA |
| Event id | 98805 |
| Address 1 | 1220 Old Alpharetta Rd Ste 320 |
| Code info | 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) |
| Postal code | 30005-3946 |
| Report date | 20260603 |
| Product type | Devices |
| Product quantity | 452,500 units |
| Reason for recall | Nitrile Exam Glove failed to meet specifications chemical permeation performance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260413 |
| Initial firm notification | Letter |
| Center classification date | 20260522 |
Overview
- Recalling FirmO&M HALYARD INC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.