Class 2 Device Recall Beyond Air, Inc

• Date Initiated by Firm: October 20, 2026
• Date Posted: November 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0436-2027
• Recall Event ID: 100222
• Product Classification: Gas, calibration (specified concentration) - Product Code BXK
• Product: NO Calibration Gas Cylinder, 45ppm; Model/Catalog Number: 80006; Software Version: N/A - No firmware/software; Product Description: Nitric Oxide Calibration Gas, 45 ppm Intended to be used with LungFit PH device (FDA PMA 200044) during pre verification checks and monthly maintenance to calibration internal NO sensors. Component: No
• Code Information: The Beyond Air product code is 8006; Mesa Gas part number is: Z166045; UDI-DI: N/A; Cylinder Numbers: C418368, C547918, C385448, C249243, C391758, C391775, C418404, C385315, C418603, C418303, C418750, C391573, C385388, C391749, C418707, C391651, C548078, C418298, C385354, C385373, C391773, C391805, C418606, C418313, C418346, C418720, C391819, C391910, C547921, C391636, C391820, C391907, C547912, C547896, C391928, C548077, C385314, C418675, C385425, C548059, C391911, C391800, C418676, C548069, C548034, C547980, C391745, C391801, C391772, C418627, C418427, C418406, C418376, C418663, C391752, C418677, C391703, C141887, C385130, C391762, C418698, C385372, C385440, C547891, C385337, C385353, C418684, C385441, C391803, C391767, C547881, C418390, C385385, C391717, C418494, C391757, C418349, C418751, C391886, C391701, C418296, C418291, C418685, C391724, C391864, C391927, C385142, C385331, C385131, C391768, C391779, C391614, C418514, C418403, C418353, C418604, C418742, C391885, C547934, C547894, C547933, C547908, C547885, C385358, C418607, C391750, C391780, C391753, C391751, C391740, C391746, C391571, C418686, C418697, C418708, C418719, C418314, C418355, C418743, C418741, C418678, C548057, C548075, C548068, C548061, C548056, C548063, C548074, C548066, C548064
• FEI Number: 3020846279
• Recalling Firm/ Manufacturer: Beyond Air Inc.; 900 Stewart Ave; Ste 301; Garden City NY 11530-4869
• Manufacturer Reason for Recall: Some NO calibration tanks may have been contaminated with O2 (from the air).
• FDA Determined Cause: Component design/selection
• Action: On October 20, 2026 URGENT: CALIBRATION GAS FOR MEDICAL DEVICE CLASS II RECALL letters were sent to customers. Actions to be taken by the Customer: If the issue is detected: - Replace the LungFit PH with another that has NOT had its NO gas sensor calibrated with the same NO cal gas cylinder - During calibration with the NO cal gas cylinder, if the NO2 value is 2ppm or higher, DO NOT use the calibration cylinder to calibrate the NO sensor. To ensure accurate NO2 values, calibrate the NO2 sensor prior to calibrating the NO sensor. - Notify Beyond Air or Distributor, and the cylinder will be replaced. - Empty the cylinder and recycle the empty cylinder at your location - DO NOT use the implicated NO cal gas cylinder to conduct a verification check or high calibration of the NO sensor of any other LungFit PH. Action to be taken by Beyond Air and its supplier (Mesa Gas): - The affected tanks/cylinders will be replaced. The plan is to replace them as quickly as possible and by the end of November 2026 at the latest. - DO NOT use the implicated tank/cylinder to conduct a verification check or high calibration of the NO sensor of any other LungFit PH.
• Quantity in Commerce: 181
• Distribution: Worldwide - US Nationwide distribution in the states of California, Tennessee, Arkansas, Nebraska, New York, North Carolina, Delaware, New Jersey, Texas, Indiana, Minnesota, Illinois, Oklahoma, Georgia, Florida, Utah and the countries of Canada, Hong Kong, Australia, Manila, Vietnam, Israel, Taiwan, Panama, Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.