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U.S. Department of Health and Human Services

Class 2 Device Recall HALYARD PUREZERO Ultraviolet Nitrile Exam Gloves

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 Class 2 Device Recall HALYARD PUREZERO Ultraviolet Nitrile Exam Glovessee related information
Date Initiated by FirmApril 13, 2026
Date PostedMay 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2230-2026
Recall Event ID 98805
510(K)NumberK200019 
Product Classification Medical Glove, Specialty - Product Code LZC
ProductHalyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Code Information 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)
FEI Number 3014421917
Recalling Firm/
Manufacturer		 O&M HALYARD INC
1220 Old Alpharetta Rd Ste 320
Alpharetta GA 30005-3946
For Additional Information ContactChristian Cook
+1-844-4259273
Manufacturer Reason
for Recall		Nitrile Exam Glove failed to meet specifications chemical permeation performance.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce452,500 units
DistributionUS Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZC
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