Device recall

Z-0535-03: Conformer - Medium (Sterile)

FDA device recall · Class II · Gulden Ophthalmics

Key facts

Recall number (Z-number) Z-0535-03
Recall event 25123
Product Conformer - Medium (Sterile)
Product code HQX
Recalling firm Gulden Ophthalmics
Recall class Class II
Status Terminated
Termination date Feb 6, 2004
510(k) numbers K972661
FEI number 2518410

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)