Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 4
FDA device recall Z-2230-2026 · posted 2026-05-22 · Open, Classified
Recall details
- Recalling firm
- O&M HALYARD INC
- Reason for recall
- Nitrile Exam Glove failed to meet specifications chemical permeation performance.
- Action taken
- On August 13, 2026, O&M Halyard, Inc. issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. O&M Halyard ask consignees to take the following actions: 1. REVIEW your inventory for the affected product code(s) and specific lot number(s). 2. DESTROY or DISCARD the product in accordance with the facility s standard disposal procedure. 3. COMMUNICATE the recall notification to your staff to ensure awareness of it. 4. If any of the affected lot(s) identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Any adverse events associated with the use of the affected product should be reported to complaints@owens minor.com. 6. RETURN the completed Field Action Response Form to OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. 7. If credit is requested, please contact the Customer Service team and send email to GM-OMRA_RECALLS@owens minor.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LZC
- Quantity affected
- 452,500 units
- Distribution
- US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
- Date initiated
- 2026-04-13
- Date posted
- 2026-05-22
- Location
- Alpharetta, GA
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