Device recall

Z-2190-2025: BostonSight SCLERAL Lens

FDA device recall · Class II · Boston Foundation For Sight

Key facts

Recall number (Z-number) Z-2190-2025
Recall event 97123
Product BostonSight SCLERAL Lens
Product code HQD
Recalling firm Boston Foundation For Sight
Recall class Class II
Status Completed
510(k) numbers K183175
FEI number 3006204913

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)