Device recall

Z-0029-2026: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

FDA device recall · Class I · NOXBOX LTD

Key facts

Recall number (Z-number) Z-0029-2026
Recall event 97516
Product NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Product code MRN
Recalling firm NOXBOX LTD
Recall class Class I
Status Open, Classified
510(k) numbers K171696
FEI number 3012796317

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)