Z-2230-2026 Class II Ongoing
FDA device recall Z-2230-2026 was initiated by O&M HALYARD INC on April 13, 2026 and is designated Class II. Reason for recall: Nitrile Exam Glove failed to meet specifications chemical permeation performance. The recall status is ongoing. Affected quantity: 452,500 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2026
- Initiation Date
- April 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 452,500 units
Product Description
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Reason for Recall
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Distribution Pattern
US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Code Information
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)