Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SurgiCounter scanner Recalled by Stryker Instruments Div. of Stryker Corporation Due to The affected scanner does not correctly interact with...

Date: March 21, 2016
Company: Stryker Instruments Div. of Stryker Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.

Affected Products

SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.

Quantity: 286

Why Was This Recalled?

The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Instruments Div. of Stryker Corporation

Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report