Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 113367
- 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:
- Cooper Surgical, Inc.
- Reason for Recall:
- Incorrect size was printed on the outer product packaging.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Product Codes/Lot Numbers:
Lot 113367
Distribution:
Distributed in: NE, MA, FL, TN, CA, ME, SC, NH, OK, TX, NM, MO, NY, PA, AZ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1018-2013
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Pessary mislabeled outer package may not reflect the size of the product contained in the package
Pessary mislabeled outer package may not reflect the size of the product contained in the package