Class II — 3M Company - Health Care Business
| Recalling firm | 3M COMPANY |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Contamination with foreign substance matter |
| Product | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R |
| Quantity | 10,000 units |
| Distribution | International distribution to the country of South Korea. |
| Initiated | 2024-08-14 |
| Classified | 2024-10-09 |
| Recall number | Z-0038-2025 |
| 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 — 3M Company - Health Care Business (Z-0038-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95273/
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