FDA Device recall Z-2544-2025

NOxBOXi Nitric Oxide Delivery System

FDA Device
Class II
ongoing
Published 2025-09-17

On 2025-09-17 the FDA classified a Class II recall of NOxBOXi Nitric Oxide Delivery System by Noxbox, citing replacement of the internal Sample Pump due to high failure rates.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2544-2025
Classification	Class II
Status	ongoing
Initiated	2023-07-19
Published	2025-09-17
Last updated	2026-09-13 11:57 UTC
Company	Noxbox
Distribution	US

Product

NOxBOXi Nitric Oxide Delivery System

Reason

Replacement of the internal Sample Pump due to high failure rates.

Identifiers

code_info	Model No. NOXBOXI; UDI: 05060541640009; Serial No. NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034… Model No. NOXBOXI; UDI: 05060541640009; Serial No. NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034, NI102152, NI102854, NI101289, NI102957, NI102642, NI101960, NI102163, NI101717, NI102928, NI101146, NI101209, NI102128, NI101751, NI101743, NI102266, NI101813, NI102037, NI102079, NI102850, NI100850, NI101221, NI101708, NI101744, NI101879, NI101905, NI101948, NI102410, NI101208, NI101354, NI101940, NI102117, NI102338, NI101002, NI101729, NI102094, NI102310, NI102676, NI102888, NI102683, NI102933, NI102537, NI101594, NI101958, NI101989, NI102104, NI102206, NI102620, NI102639, NI102696, NI102771, NI102814, NI102852, NI101147, NI102431, NI100983, NI101257, NI101353, NI101581, NI101987, NI102111, NI102308, NI102816, NI102908, NI102698, NI102725, NI102883, NI102932, NI102936, NI103084, NI101703, NI101993, NI102422, NI102485, NI102879, NI102939, NI101234, NI101821, NI102947, NI101029, NI101679, NI102031, NI102538, NI102624, NI102794, NI102839, NI102848, NI102865, NI102942,

code_info

Model No. NOXBOXI; UDI: 05060541640009; Serial No. NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034…

Model No. NOXBOXI; UDI: 05060541640009; Serial No. NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034, NI102152, NI102854, NI101289, NI102957, NI102642, NI101960, NI102163, NI101717, NI102928, NI101146, NI101209, NI102128, NI101751, NI101743, NI102266, NI101813, NI102037, NI102079, NI102850, NI100850, NI101221, NI101708, NI101744, NI101879, NI101905, NI101948, NI102410, NI101208, NI101354, NI101940, NI102117, NI102338, NI101002, NI101729, NI102094, NI102310, NI102676, NI102888, NI102683, NI102933, NI102537, NI101594, NI101958, NI101989, NI102104, NI102206, NI102620, NI102639, NI102696, NI102771, NI102814, NI102852, NI101147, NI102431, NI100983, NI101257, NI101353, NI101581, NI101987, NI102111, NI102308, NI102816, NI102908, NI102698, NI102725, NI102883, NI102932, NI102936, NI103084, NI101703, NI101993, NI102422, NI102485, NI102879, NI102939, NI101234, NI101821, NI102947, NI101029, NI101679, NI102031, NI102538, NI102624, NI102794, NI102839, NI102848, NI102865, NI102942,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2544-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.