FDA Medical devices recall ·
NOxBOXi Nitric Oxide Delivery System recall
- Recall number
- Z-2544-2025
- Date
- (initiated July 19, 2023)
- Company / brand
- Noxbox Ltd
Unit 1, Sittingbourne, N/A, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,667 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
NOxBOXi Nitric Oxide Delivery System
Why was it recalled?
Replacement of the internal Sample Pump due to high failure rates.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, NI102999, NI101077, NI101600, NI102121, NI102424, NI102545, NI102812, NI102838, NI102849, NI102861, NI102877, NI102885, NI102944, NI101136, NI101340, NI101416, NI101916, NI101937, NI102060, NI102815, NI102437, NI102513, NI102541, NI102762, NI102828, NI102836, NI101380, NI101712, NI102062, NI102123, NI102278, NI102343, NI102492, NI102853, NI102963, NI102540, NI102727, NI102350, NI102382, NI102507, NI102604, NI102625, NI102658, NI102871, NI101095, NI102584, NI102726, NI102823, NI102832, NI102855,
Distribution
US Nationwide distribution in the state of TN.
States: Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2544-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.