FDA Medical devices recall ·
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771… recall
- Recall number
- Z-2230-2026
- Date
- (initiated April 13, 2026)
- Company / brand
- O&M Halyard, Inc.
1220 Old Alpharetta Rd Ste 320, Alpharetta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 452,500 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Why was it recalled?
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
Distribution
US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
States: California Georgia Massachusetts North Carolina New Jersey New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2230-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.