Device recall

Z-0040-2025: Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper…

FDA device recall · Class II · Inspire Medical Systems Inc.

Key facts

Recall number (Z-number) Z-0040-2025
Recall event 95230
Product Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Product code MNQ
Recalling firm Inspire Medical Systems Inc.
Recall class Class II
Status Open, Classified
FEI number 3007666314

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)