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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Stryker Communications
- 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
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