SurgiCount+ Software Application-indicated as an adjunctive… — Class II medical device recall Z-2463-2023
Ongoing recall by Stryker Corporation, reported 2023-09-06, distributed nationwide. Potential for current software to miscount when scanning in multiple sponge-products from the same unique spon
| Recall number | Z-2463-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2023-07-10 |
| Classified | 2023-08-25 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 57 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07613327543094 |
Product
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
Reason for recall
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
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-2463-2023. 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.