FDA Device recall Z-1452-2022
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090 by Stryker Instruments Div, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1452-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-15 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Instruments Div |
| Distribution | KS, ME |
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.
Identifiers
| code_info | UDI-DI (GTIN): 07613327543094; Serial Numbers: GK404E00828 GK404E00933 GK404E00959 GK404E01157 GK405E00282 GK405E…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1452-2022%22
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