Class II — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL |
| Quantity | 940,203 total units |
| Distribution | US Nationwide. Canada, UAE |
| Initiated | 2024-11-01 |
| Classified | 2024-12-11 |
| Recall number | Z-0675-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-0675-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95727/
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