Medical Device Recall: Z-0029-2026

FDA Recalls dataset · Firm: NOXBOX LTD · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2025-09-09 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-2026.

Recall Res Number
Z-0029-2026
Recalling Firm / Manufacturer
NOXBOX LTD
FEI Number
3012796317
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2025-09-09
Date Posted
2025-10-06
Date Terminated
N/A
Product Code
MRN
Event Number
97516
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.
Action Details On September 9, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers: Actions to be taken: - Customers should ensure that all affected personnel are provided with a copy of the recommendations in this letter. - Users should avoid rapidly pressing buttons in quick succession (e.g., go to next screen, accept a value, change a value, backing out, repeating this) as it is necessary to allow an opportunity for the device to respond to user inputs before the next command to avoid a potential software interruption and subsequent restart. - NOxBOX Ltd. is asking customers in the U.S. to return the attached response form to Linde Gas & Equipment as instructed on the form. Recalling firm actions: NOxBOX Ltd. is in the process of developing a new software version that will include a modification to the software to resolve this issue, which will be released pending required regulatory review and approval. Once the software version is released, NOxBOX Ltd. will be back in contact with you to update your device software. If you have any questions about this notice or need assistance, please reach out to your local Clinical Educator or the Customer Excellence Center at 1-833-NOX-VENT (669-8368) or at LG.US.NOXIVENT@Linde.com.
Distribution Pattern Domestic: TN;
Code Information / Serial Numbers Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

Related Establishments / Registrations

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