Device recall

Z-1357-2024: Phantom 2 Nasal Vented Mask

FDA device recall · Class I · SleepNet Corporation

Key facts

Recall number (Z-number) Z-1357-2024
Recall event 94169
Product Phantom 2 Nasal Vented Mask
Product code BZD
Recalling firm SleepNet Corporation
Recall class Class I
Status Open, Classified
510(k) numbers K211274
FEI number 1222088

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)