Recall Z-2230-2026 ยท LZC Medical Glove, Specialty
O&M HALYARD INC
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
| Date | May 22, 2026 (initiated Apr 13, 2026) |
| Status | Open, Classified |
| Reason | Nitrile Exam Glove failed to meet specifications chemical permeation performance. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 452,500 units |
| Distribution | US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powd Hartalega NGC Sdn. Bhd., Apr 6, 2020 |