FDA Medical Device Recalls (openFDA)
O&M HALYARD INC: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
- Recall number
- Z-2230-2026
- Recalling firm
- O&M HALYARD INC
- Product
- Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
- Status
- Open, Classified
- Initiated
- 2026-04-13
- Posted
- 2026-05-22
- Terminated
- not on file
- 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 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.
- Quantity
- 452,500 units
- Distribution
- US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K200019"]
- PMA numbers
- not on file
- Product code
- LZC
- Firm FEI
- 3014421917
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28