Device recall

Z-0274-2025: KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s…

FDA device recall · Class II · King Systems Corp. dba Ambu, Inc.

Key facts

Recall number (Z-number) Z-0274-2025
Recall event 95451
Product KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
Product code CAE
Recalling firm King Systems Corp. dba Ambu, Inc.
Recall class Class II
Status Open, Classified
FEI number 1824226

At a glance

  • None 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)