Stryker Communications FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. Matched by name to SYK.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001Class IIFeb 23, 2026Surgical light assembly may not adequate support the weight	Surgical light assembly may not adequate support the weight of the ceiling cover.	Class IIDevices	Feb 23, 2026
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034Class IIJul 15, 2025Surgical lights have stress lines forming on the powder coat	Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping	Class IIDevices	Jul 15, 2025
Chromophare Surgical Light System , REF CH00000001Class IIFeb 8, 2024Due to insufficient mounting force the stability of surgical	Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.	Class IIDevices	Feb 8, 2024
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected withClass IIJan 29, 2021The manufacturer has become aware that there is a likelihood	The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Cap	Class IIDevices	Jan 29, 2021