O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- O&M HALYARD, INC.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Product Codes/Lot Numbers:
UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0729-2025
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