Device recall

Z-0939-2026: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog…

FDA device recall · Class I · Alcon Research LLC

Key facts

Recall number (Z-number) Z-0939-2026
Recall event 98055
Product Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by…
Product code LRO
Recalling firm Alcon Research LLC
Recall class Class I
Status Open, Classified
FEI number 1610287

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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)