Class I — Windstone Medical Packaging, Inc.
| Recalling firm | WINDSTONE MEDICAL PACKAGING, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Sterility assurance for saline included in surgical kits cannot be guaranteed. |
| Product | Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO |
| Quantity | 475 kits |
| Distribution | US: FL, IL, CA OUS: None |
| Initiated | 2023-12-22 |
| Classified | 2024-02-16 |
| Recall number | Z-1082-2024 |
| 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 I recall — Windstone Medical Packaging, Inc. (Z-1082-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93807/
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