Device recall

Z-1390-2025: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner…

FDA device recall · Class I · Covidien

Key facts

Recall number (Z-number) Z-1390-2025
Recall event 96371
Product Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Product code JOH
Recalling firm Covidien
Recall class Class I
Status Open, Classified
510(k) numbers K150844
FEI number 2936999

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)