CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 00081317006671 00081317006794 00081317006800
- 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:
- Mentor Texas, LP.
- Reason for Recall:
- Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Product Codes/Lot Numbers:
00081317006671 00081317006794 00081317006800
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1681-2026
Related Recalls
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.