🔍 RecallPedia

Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

Class I - Dangerous
🏥 Medical Devices Recalled: April 13, 2015 United Surgical Associates Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Product #: i-94103 Elastic Ankle Support SM Lot#: AP20140815001 Product #: i-94105 Elastic Ankle Support MD Lot#: AP20140815001 Product #: i-94107 Elastic Ankle Support LG Lot#: AP20140815001
  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:
United Surgical Associates
Reason for Recall:
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

Product Codes/Lot Numbers:

Product #: i-94103 Elastic Ankle Support SM Lot#: AP20140815001 Product #: i-94105 Elastic Ankle Support MD Lot#: AP20140815001 Product #: i-94107 Elastic Ankle Support LG Lot#: AP20140815001

Distribution:

Distributed in: HI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1664-2015

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