Device recall

Z-1892-2025: BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or…

FDA device recall · Class II · Civco Medical Instruments Co. Inc.

Key facts

Recall number (Z-number) Z-1892-2025
Recall event 96814
Product BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Product code ITX
Recalling firm Civco Medical Instruments Co. Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K093713
FEI number 1937223

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)