🔍 RecallPedia

Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

Class I - Dangerous
🏥 Medical Devices Recalled: June 19, 2015 CooperSurgical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    LOT 156966
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
CooperSurgical, Inc.
Reason for Recall:
Incorrect expiration date on outer carton kit label
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

Product Codes/Lot Numbers:

LOT 156966

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2098-2015

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