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FDA recall, , Moderate risk

Halyard Purezero Ultraviolet Nitrile Exam Gloves

Nitrile exam gloves failed to meet chemical permeation performance specifications.

What happened

O&M Halyard Inc. of Alpharetta, Georgia, recalled Halyard Purezero Ultraviolet Nitrile Exam Gloves after the gloves failed to meet specifications for chemical permeation performance. The recall began April 13, 2026, and involved 452,500 units distributed in California, Georgia, Massachusetts, North Carolina, New Jersey, and New York. The FDA added the recall to its Enforcement Report and classified it on May 22, 2026, and it was in the FDA's weekly enforcement report on June 3, 2026.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Are your gloves affected?

Affected if its UDI-DI is listed.

A UDI-DI is the device identifier printed with the barcode on the device label.

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

    UDI-DI
    • 30680651487712
    • 20680651487715
    • 90680651487714
    • 30680651487729
    • 20680651487722
    • 90680651487721
    • 30680651487736
    • 20680651487739
    • 90680651487738
    • 30680651487743
    • 20680651487746
    • 90680651487745
    • 30680651487750
    • 20680651487753
    • 90680651487752

Recall details

Company began the recall
Sold in

US Nationwide distribution in the states of Georgia, California, New Jersey, Massachusetts, New York, North Carolina.

Company
O&M HALYARD INCAlpharetta, Georgia
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98805
Recall number
Z-2230-2026
Quantity recalled
452,500 units

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)