Device recall

Z-0004-2025: Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric…

FDA device recall · Class I · Mercury Enterprises, Inc. dba Mercury Medical

Key facts

Recall number (Z-number) Z-0004-2025
Recall event 95303
Product Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Product code BTL
Recalling firm Mercury Enterprises, Inc. dba Mercury Medical
Recall class Class I
Status Open, Classified
510(k) numbers K093913
FEI number 1024404

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)