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Bridge to Life Ltd

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Belzer UW Cold Storage Solution	BUW-006	FDA UDI	Class II	Active
EasiSlush	BTLE-1250	FDA UDI	Class II	Active
Belzer UW Cold Storage Solution	BUW-006	FDA UDI	Class II	Active
Belzer UW Cold Storage Solution	BUW-006	FDA UDI	Class II	Active
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)	K243840	FDA 510(k)	Class II	Active
Cannula for Organ Perfusion	K203262	FDA 510(k)	Class II	Active
OrganProtex HTK Solution	K241239	FDA 510(k)	Class II	Active
Belzer UW® Cold Storage Solution (BTLBUW-001)	K243384	FDA 510(k)	Class II	Active
VitaSmart Hypothermic Oxygenated Perfusion System	DEN250009	FDA 510(k)	Class II	Active
EasiSlush	K191006	FDA 510(k)	Class II	Active
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)	K243618	FDA 510(k)	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
Jun 12, 2025	Z-2157-2025	—	open, classified	The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.