Recall archive / FDA device enforcement
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, ... — FDA record Z-1452-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 44 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1452-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 07613327543094; Serial Numbers: GK404E00828 GK404E00933 GK404E00959 GK404E01157 GK405E00282 GK405E00642 GK405E00671 GK405E00675 GK405E00693 GK405E00707 GK405E00757 GK405E00827 GK405E00857 GK405E00914 GK403E00537 GK404E00494 GK405E00176 GK405E00655 GK405E00723 GK403E00031 GK404E00638 GK404E00640 GK404E00700 GK404E00866 GK404E00887 GK404E00945 GK404E01113 GK404E01119 GK404E01121 GK404E01123 GK404E01170 GK404E01171 GK405E00602 GK49CE00058 GK404E00032 GK404E00034 GK404E00043 GK404E00262 GK404E00287 GK404E00287 211071 211115 211265 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The products were distributed to the following US states: KS and ME.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 27, 2022
- Recall initiation date
- Jun 15, 2022
- Center classification date
- Jul 21, 2022
- Termination date
- Apr 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.