🔍 RecallPedia

Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

Class I - Dangerous
🏥 Medical Devices Recalled: April 29, 2021 Exact Medical Manufacturing Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191
  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:
Exact Medical Manufacturing, Inc.
Reason for Recall:
No 510k for the product to be used in a natural or surgical opening to the body
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

Product Codes/Lot Numbers:

Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191

Distribution:

Distributed in: US, FL, MT, NY, OH, GA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1921-2021

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