Reported Jul 27, 2022 · Terminated
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying,…
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
- Lot codes and dates
- UDI-DI (GTIN)07613327543094
- Serial Numbers
GK404E00828GK404E00933GK404E00959GK404E01157GK405E00282GK405E00642GK405E00671GK405E00675GK405E00693GK405E00707GK405E00757GK405E00827GK405E00857GK405E00914GK403E00537GK404E00494GK405E00176GK405E00655GK405E00723GK403E00031GK404E00638GK404E00640GK404E00700GK404E00866GK404E00887GK404E00945GK404E01113GK404E01119GK404E01121GK404E01123GK404E01170GK404E01171GK405E00602GK49CE00058GK404E00032GK404E00034GK404E00043GK404E00262GK404E00287GK404E00287211071211115211265
- Amount recalled
- 44 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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