OrganOx Ltd

FDA Regulatory Profile

OrganOx Ltd appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0501-2025, Class II) was initiated on October 15, 2024.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0501-2025Class IIOrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. ModOctober 15, 2024