Recall Z-2230-2026— O&M HALYARD INC

Name: FDA recall Z-2230-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-13

Class II · Ongoing

Class II FDA medical device recall by O&M HALYARD INC, initiated 2026-04-13. It names one FDA 510(k) clearance: K200019. Product: 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..

Recalling firm: O&M HALYARD INC
Classification: Class II
Status: Ongoing
Initiated: 2026-04-13
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K200019 — Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)Hartalega NGC Sdn. Bhd.·cleared 2020-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Nitrile Exam Glove failed to meet specifications chemical permeation performance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.