Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0027-2025 — Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

U.S. FDA — Device Enforcement · United States · 2024-08-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0027-2025
Date of alert
2024-08-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Windstone Medical Packaging, Inc.
Product category
device
Product type
Devices
Reported risk: Due to convenience kits containing a kit component that is under a recall action for improper use.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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