Device recall

Z-1293-2025: Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17…

FDA device recall · Class II · Alcon Research LLC

Key facts

Recall number (Z-number) Z-1293-2025
Recall event 96285
Product Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
Product code LRO
Recalling firm Alcon Research LLC
Recall class Class II
Status Open, Classified
510(k) numbers K880961
FEI number 1610287

At a glance

  • 1–9 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)