Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.),
Summary
The FDA issued a Class II for Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), by O&M HALYARD INC. Reason: Nitrile Exam Glove failed to meet specifications chemical permeation performance..
Details
Source
Device Recall
External ID
Z-2230-2026
Action Date
2026-06-03
Status
Ongoing
Category
device
Product Description
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Lot/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)
Quantity Affected: 452,500 units
Reason for Recall
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Distribution
US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-13
Company
Alpharetta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 129 device recalls issued in the same week, part of 403 device-related FDA actions this month.
O&M HALYARD INC has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (O&M HALYARD INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does O&M HALYARD INC have FDA actions?
O&M HALYARD INC has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2230-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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