Facility

NOXBOX LIMITED

5 recall(s) on record — most severe on record: Class I.

Key facts

5recalls · worst Class I

—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)	3012796317
Establishment type	Manufacture Medical Device
Location	1 Eurolink Gateway Sittingbourne Kent, GB ME10 3AG
Registration status	Active · expires 2026
Parent company	NOxBOX Limited (owner-operator 10058545)
Brand names	NOxBOXi Nitric Oxide Delivery and Monitoring System

Activity by year

Recalls (5)

Devices registered here (5)

Apparatus, Nitric Oxide, Backup Delivery
Product code MRO (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5165
Apparatus, Nitric Oxide Delivery
Product code MRN (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5165
Analyzer, Nitric Oxide
Product code MRP (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2380
Analyzer, Gas, Oxygen, Gaseous-Phase
Product code CCL (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1720
Analyzer, Nitrogen Dioxide
Product code MRQ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2385

Recalls & enforcement

Class IIOngoing2026-08-19
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Class IOngoing2025-09-09
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional …
Class IOngoing2025-09-09
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Class IIOngoing2023-07-19
Replacement of the internal Sample Pump due to high failure rates.
Class ITerminated2023-05-03
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interru…

All facilities operated by NOxBOX 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. “NOXBOX LIMITED (FEI 3012796317) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012796317-noxbox-limited/

Not open yet

Alerts for NOXBOX LIMITED

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.