Device recall

Z-0031-2025: Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem…

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

Key facts

Recall number (Z-number) Z-0031-2025
Recall event 95306
Product Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Product code LRO
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
  • 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)