FDA Device recall Z-1297-2021
S-Series Equipment Management System
- FDA Device
- Class II
- ongoing
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of S-Series Equipment Management System by Stryker Communications, citing 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 bra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1297-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-01-29 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Communications |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 2258046 2863490 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1297-2021%22
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