HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
NOXBOX Recalls Nitric Oxide Delivery System Over Diagnostic Errors
NOXBOX recalled 1,667 Nitric Oxide Delivery Systems on September 9, 2025. The recall follows reports of internal faults caused by rapid button selections. The company advises patients and healthcare providers to stop using the device immediately.
Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- NOXBOX
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NOXBOX LTD or your healthcare provider for instructions. Notification method: Letter
Product Details
The recalled product is the NOxBOXi Nitric Oxide Delivery System, Model Number NOXBOX-I. Approximately 1,667 units were distributed domestically in Tennessee.
The Hazard
The device can experience an internal fault or system diagnostic error when users rapidly press buttons without waiting for a response. This malfunction can pose significant risks to patients.
Reported Incidents
No incidents or injuries have been reported related to this recall. The product was classified as Class I, indicating a high hazard level.
What to Do
Stop using the device immediately. Follow the manufacturer's recall instructions and contact NOXBOX LTD or your healthcare provider for further guidance.
Contact Information
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0029-2026.
Key Facts
- Recall date: September 9, 2025
- Quantity recalled: 1,667 units
- Distribution: Tennessee
- Hazard classification: Class I
- Manufacturer: NOXBOX LTD
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeNitric Oxide Delivery System
Sold At
Unknown
Product Details
Brand
Categories
Model Numbers
NOXBOX-I
NBL
REQNOXBOXI
UDI-DI: 05060541640009
Affected States
TN
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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