Recall Ledger

Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 recall (O&M HALYARD INC)

Medical deviceClass IIOngoing

Summary: O&M HALYARD INC is recalling Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl). Reason: Nitrile Exam Glove failed to meet specifications chemical permeation performance.

What is being recalled

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

Why

Nitrile Exam Glove failed to meet specifications chemical permeation performance.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC. (states named: California, Georgia, Massachusetts, North Carolina, New Jersey, New York)

How to tell if yours is 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)

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2230-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedApril 13, 2026
ReportedJune 3, 2026
CompanyO&M HALYARD INC
Company locationAlpharetta, GA, United States
Initiated byVoluntary: Firm initiated
Quantity452,500 units

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