S-Series Equipment Management System — Class II medical device recall Z-1297-2021
Ongoing recall by Stryker Communications, reported 2021-03-31, distributed nationwide. The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Cap
| Recall number | Z-1297-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Communications, Flower Mound, TX, United States |
| Recall initiated | 2021-01-29 |
| Classified | 2021-03-24 |
| Reported by FDA | 2021-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,393 units |
| UPC / GTIN / UDI-DI | 07613327400502 |
| Serial numbers | 2258046, 2863490 |
| Model numbers | 07613327400502, P38198ASM |
Product
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD
Reason for recall
The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.
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-1297-2021. 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.