Device recall

Z-0746-2025: Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI…

FDA device recall · Class II · Becton, Dickinson and Company, BD Bio Sciences

Key facts

Recall number (Z-number) Z-0746-2025
Recall event 95729
Product Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste…
Product code OYE
Recalling firm Becton, Dickinson and Company, BD Bio Sciences
Recall class Class II
Status Open, Classified
510(k) numbers K170974, K201814
FEI number 3027394506

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)