SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN 07613327543094 Software Version: 2.1.8 & 2.20
  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:
Stryker Corporation
Reason for Recall:
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

Product Codes/Lot Numbers:

GTIN 07613327543094 Software Version: 2.1.8 & 2.20

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2463-2023

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