← FDA ENFORCEMENT
Z-2230-2026Class II

O&M HALYARD INC

Recalling firm
O&M HALYARD INC
Product type
Device
Status
Ongoing
Report date
2026-06-03
Distribution
US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Firm state
GA
Product quantity
452,500 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Nitrile Exam Glove failed to meet specifications chemical permeation performance.

Product description

Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

Code / lot 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)

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.