Device recall

Z-3138-2026: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

FDA device recall · Class II · Windstone Medical Packaging, Inc.

Key facts

Recall number (Z-number) Z-3138-2026
Recall event 99658
Product AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Product code KDD
Recalling firm Windstone Medical Packaging, Inc.
Recall class Class II
Status Open, Classified
FEI number 1000125955

At a glance

  • None 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)