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BTE TECHNOLOGIES

United States·US-MF-000041076

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Primus	Primus+	FDA UDI	Class II	Unknown
Evaluator	Evaluator EV	FDA UDI	Class II	Unknown
Simulator II	Sim II 03	FDA UDI	Class I	Active
Er	ER	FDA UDI	Class II	Unknown
Evaluator EV2	EV2	FDA UDI	Class II	Unknown
Provider Test Kit (PTK)	1	FDA UDI	Class II	Active
Simulator II	Sim II 5	FDA UDI	Class I	Active
MCU Multi-Cervical Unit	MCU 2	EUDAMEDFDA UDI	Class II	Active
Evj	Evaluator EVJ	FDA UDI	Class II	Active
Prism	Prism1	FDA UDI	Class II	Active
Evaluator	Evaluator	FDA UDI	Class II	Active
EvalTech	EvalTech	FDA UDI	Class II	Active
PrimusRS	PrimusRS	FDA UDI	Class II	Active
Eccentron	LE1	FDA UDI	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 9, 2015	Z-1986-2015	—	terminated	On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.