Device recall

Z-2517-2025: FloPatch FP120, REF: FP120-FOT01-005

FDA device recall · Class III · Flosonics Medical (R/A 1929803 ONTARIO CORP.)

Key facts

Recall number (Z-number) Z-2517-2025
Recall event 97427
Product FloPatch FP120, REF: FP120-FOT01-005
Product code DPW
Recalling firm Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Recall class Class III
Status Open, Classified
510(k) numbers K200337, K223843
FEI number 3015139886

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)