The Recall Desk
HighFDA (Devices)·Z-1297-2021·Announced 2021-03-31

Stryker S-Series Equipment Management System Recall for Brake Disengagement Risk

Stryker is recalling S-Series Equipment Management Systems because capacitive touch controls may disengage when electrocautery devices are in use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential mechanical failure during medical procedures.

Plain-English summary

Stryker Communications is recalling the S-Series Equipment Management System, Model Number 0682400550, due to a potential safety issue. The manufacturer identified a likelihood that the capacitive touch controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.

The recall affects 1,393 units distributed worldwide, including nationwide distribution in the United States and in Canada. Specific affected components include P38198, P38199, P40553, P40554, and P46269. The source text does not specify a particular action for consumers or healthcare facilities to take, nor does it report any injuries or illnesses associated with this defect.

The recalled product

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 H
Affected units
1,393

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 2258046 2863490

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically: