Device recall

Z-0343-2022: Puritan Bennett 980 Series Ventilator, 980U1ESDIUC

FDA device recall · Class I · Covidien Llc

Key facts

Recall number (Z-number) Z-0343-2022
Recall event 88987
Product Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Product code CBK
Recalling firm Covidien Llc
Recall class Class I
Status Terminated
Termination date Jul 9, 2024
510(k) numbers K193056
FEI number 1282497

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)