Stryker Instruments Div. of Stryker Corporation 2022-07-27 Health serious FDA
Health · FDA · Recall #FDA-Z-1452-2022
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. … Recall
Issued July 27, 2022 · Stryker Instruments Div. of Stryker Corporation
In July 2022, Stryker Instruments Div. of Stryker Corporation recalled the SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Instruments Div. of Stryker Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Stryker Instruments Div. of Stryker Corporation
- Category
- Health
- Recall date
- July 27, 2022
- Units affected
- Not reported
- Sold at
- The products were distributed to the following US states: KS and ME.
- Recall number
- FDA-Z-1452-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Instruments Div. of Stryker Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.