Device recall

Z-0718-2024: SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

FDA device recall · Class II · Olympus Corporation of the Americas

Key facts

Recall number (Z-number) Z-0718-2024
Recall event 93629
Product SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Product code GEX
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Open, Classified
510(k) numbers K183647
FEI number 2429304

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)