Class 2 Device Recall O&M Halyard

• Date Initiated by Firm: November 08, 2024
• Date Posted: December 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0729-2025
• Recall Event ID: 95804
• 510(K)Number: K823078 K831148
• Product Classification: Mask, surgical - Product Code FXX
• Product: O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
• Code Information: UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28
• Recalling Firm/ Manufacturer: O&M HALYARD, INC.; 9120 Lockwood Blvd; Mechanicsville VA 23116-2015
• Manufacturer Reason for Recall: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
• FDA Determined Cause: Nonconforming Material/Component
• Action: O&M Halyard issued Urgent: Product Field Action via email on 11/8/24 to Distributors and End-Users. Letter states reason for recall, health risk and action to take: Customers (end-users): 1. REVIEW your inventory for the affected product code and specific lot number. 2. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 3. COMMUNICATE this Field Action to staff to ensure awareness of it. 4. 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. 5. Any adverse events associated with the use of the affected product should be reported to complaints@owens-minor.com. 6. If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: 1. REVIEW your inventory for the affected product code and specific lot number. 2. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 3. COMMUNICATE this voluntary Field Action to staff to ensure awareness of it. 4. If any of the affected lot identified above was further distributed, please ensure all end-users are appropriately notified of this Field Action 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. If you have any questions, please email OMRA_RECALLS@owens-minor.com using the Event # FA-2024-034 in the header of the response.
• Quantity in Commerce: 637 cases
• Distribution: Nationwide
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = FXX; 510(K)s with Product Code = FXX