Stryker SurgiCounter Scanner Recalled for Software Interaction Errors
Stryker is recalling 286 SurgiCounter scanners because they may display error messages and fail to display software version numbers correctly in the SC360 application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software interaction defect without reporting any hospitalizations, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions where harm has not been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 286 units of the SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. The affected models are 0694-097-000 and 0694-097-001. These devices are indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
The recall is due to a software defect where the affected scanner does not correctly interact with the SC360 software. When docked pre- or post-operatively, the scanner may display an error message (code=2). Additionally, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
The affected units were distributed nationwide in the United States between November 1, 2015, and December 17, 2015. Distribution occurred in the states of AR, AZ, CA, CT, FL, GA, IN, LA, MD, MN, MO, MS, NJ, NM, NY, OH, SC, SD, TN, TX, and UT. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 286
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number(s): 0694-097-000 0694-097-001 Units individually serialized
Distribution
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