Stryker Corporation: SurgiCount+ Software Recalled for Potential Sponge Miscounting Risk

Agency Publication Date: August 25, 2023

Summary

Stryker Corporation has recalled 57 units of its SurgiCount+ Software Application, versions 2.1.8 and 2.20. This software is used during surgical procedures to help medical staff count and track RFID-tagged absorbent sponges. The recall was initiated because the software may fail to count correctly when scanning multiple sponge products of the same unique type, which could lead to inaccurate records of materials used during surgery.

Risk

A software error can cause the system to miscalculate the number of sponges used during a procedure. This creates a risk that a surgical sponge could be unintentionally left inside a patient, potentially leading to infections, complications, or the need for additional corrective surgery.

What You Should Do

Identify if your facility is using SurgiCount+ Software Application Version 2.1.8 or 2.20 by checking the system settings or software information screen.
Verify if your equipment matches Product Code 0694-002-090 and GTIN 07613327543094.
Contact your healthcare provider or Stryker Corporation immediately to determine if your software requires an update or specific corrective action to ensure accurate sponge counting.
Follow any specific technical instructions provided by Stryker in their initial notification letter dated July 10, 2023.
For additional information or questions regarding this recall, contact Stryker Corporation directly at their Portage, Michigan headquarters or call the FDA's medical device recall line at 1-888-463-6332.

Your Remedy Options

Other Action

Contact the manufacturer for technical guidance and software updates.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SurgiCount+ Software Application

Model / REF:

0694-002-090

UPC Codes:

07613327543094

Lot Numbers:

Software Version: 2.1.8

Software Version: 2.20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92713

Status: Active

Manufacturer: Stryker Corporation

Sold By: Stryker Corporation

Manufactured In: United States

Units Affected: 57 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility is using SurgiCount+ Software Application Version 2.1.8 or 2.20 by checking the system settings or software information screen.

Verify if your equipment matches Product Code 0694-002-090 and GTIN 07613327543094.

Contact your healthcare provider or Stryker Corporation immediately to determine if your software requires an update or specific corrective action to ensure accurate sponge counting.

Follow any specific technical instructions provided by Stryker in their initial notification letter dated July 10, 2023.

For additional information or questions regarding this recall, contact Stryker Corporation directly at their Portage, Michigan headquarters or call the FDA's medical device recall line at 1-888-463-6332.