SurgiCount+ Surgical Sponge Counting Software Miscounting Recalled
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with potential for miscounting surgical sponges. No illnesses or injuries have been reported. It qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
Stryker Corporation is recalling the SurgiCount+ Software Application, Medical Device Product Code 0694-002-090 (Software Versions 2.1.8 and 2.20). This software is designed as an adjunctive technology for counting, displaying, and recording the number of RFID-tagged absorbent articles used during surgical procedures.
The software has potential to miscount when scanning multiple sponge-products from the same unique sponge-pack type. This counting error could result in inaccurate records of surgical items used in procedures.
The recall affects 57 units that have been distributed nationwide in the United States. Healthcare facilities and surgical centers using the affected software versions may be impacted.
The recalled product
- Product
- 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;
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 57
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)
- GTIN 07613327543094 Software Version: 2.1.8 & 2.20
Distribution
Distributed nationwide across the United States.
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