FDA Medical Device Recalls (openFDA)
NOXBOX LTD: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Recall number
- Z-0029-2026
- Recalling firm
- NOXBOX LTD
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Status
- Open, Classified
- Initiated
- 2025-09-09
- Posted
- 2025-10-06
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 1667 units
- Distribution
- Domestic: TN;
- Lot, serial or model codes
- Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
- 510(k) numbers
- ["K171696","K201339","K220898","K231823","K233251"]
- PMA numbers
- not on file
- Product code
- MRN
- Firm FEI
- 3012796317
- Firm city
- Sittingbourne
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28