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

Recall Z-0674-2025 — Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

U.S. FDA — Device Enforcement · United States · 2024-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0674-2025
Date of alert
2024-11-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health 200, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50192253048252
Reported risk: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.