SurgiCount+ System Application — Class II medical device recall Z-1452-2022
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2022-07-27, distributed in KS, ME. When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted
| Recall number | Z-1452-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2022-06-15 |
| Classified | 2022-07-21 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-04-05 |
| Distributed | KS, ME |
| Quantity | 44 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07613327543094 |
| Serial numbers | 211071, 211115, 211265, GK403E00031, GK403E00537, GK404E00032, GK404E00034, GK404E00043, GK404E00262, GK404E00287, GK404E00494, GK404E00638, GK404E00640, GK404E00700, GK404E00828, GK404E00866, GK404E00887, GK404E00933, GK404E00945, GK404E00959, GK404E01113, GK404E01119, GK404E01121, GK404E01123, GK404E01157 and 17 more |
| Model numbers | 0694-002-090 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1452-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.