Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential breach in pouch packaging which could lead to loss of sterility. |
| Product | Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. |
| Quantity | 220 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-02-13 |
| Classified | 2025-03-14 |
| Recall number | Z-1369-2025 |
| 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 — MEDLINE INDUSTRIES, LP - Northfield (Z-1369-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96401/
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