SurgiCounter scanner — Class II medical device recall Z-1379-2016
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-04-20, distributed nationwide. The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the
| Recall number | Z-1379-2016 |
|---|---|
| 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 | 2016-03-21 |
| Classified | 2016-04-13 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 286 |
| Reason classes | software |
| Serial numbers | 1525901643, 1525901653, 1525901663, 1525901673, 1525901683, 1525901693, 1525901703, 1525901713, 1525901723, 1525901733, 1526106133, 1526106143, 1526106153, 1526106163, 1526106173, 1526106183, 1526106193, 1526106203, 1526106213, 1526106223, 1526106233, 1526106243, 1526106293, 1526106303, 1526106313 and 261 more |
| Model numbers | 0694-097-000, 0694-097-001 |
Product
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Reason for recall
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
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-1379-2016. 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.