Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown — Class II medical device recall Z-0675-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2024-12-18, distributed nationwide. Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and
| Recall number | Z-0675-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2024-11-01 |
| Classified | 2024-12-11 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA |
| Quantity | 940,203 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 20885380166638, 20885380166645, 20885380166652, 20885380166669, 20885380166676, 20885380166683, 50885380166639, 50885380166646, 50885380166653, 50885380166660, 50885380166677, 50885380166684 |
| Lot numbers | AT6588-2XL |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0675-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.