Facility

ORGANOX LIMITED

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011560054
Establishment type	Repack or Relabel Medical Device
Location	3500 John Smith Drive Oxford Oxfordshire, GB OX4 2WB
Registration status	Active · expires 2026
Parent company	OrganOx Limited (owner-operator 10084836)

Activity by year

Recalls (1)

Devices registered here (1)

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Product code DRY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4330

Recalls & enforcement

Class IIOngoing2024-10-15
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

All facilities operated by OrganOx Limited

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ORGANOX LIMITED (FEI 3011560054) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011560054-organox-limited/

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