medical HIGH RISK Updated 2025-10-15

NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX

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Recalled Product

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

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Hazard / Issue

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.

Issued by

FDA

Affected States: TN
Lot/Code Info: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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