Z-0029-2026 Class I Ongoing
FDA device recall Z-0029-2026 was initiated by NOXBOX LTD on September 9, 2025 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 1667 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- September 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1667 units
Product Description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Reason for Recall
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.
Distribution Pattern
Domestic: TN;
Code Information
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.