🔍 RecallPedia

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Class I - Dangerous
🏥 Medical Devices Recalled: January 13, 2016 PMBS Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    ALL distributed S.C.O.R.E.S. units are affected.
  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:
PMBS, LLC
Reason for Recall:
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Product Codes/Lot Numbers:

ALL distributed S.C.O.R.E.S. units are affected.

Distribution:

Distributed in: FL, GA, MN, NY, OH, OR, SC, TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1266-2016