FDA Device recall Z-1082-2024
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- FDA Device
- Class I
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class I recall of Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO by Windstone Medical Packaging, citing sterility assurance for saline included in surgical kits cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1082-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-22 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Windstone Medical Packaging |
| Distribution | CA, FL, IL |
Product
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Reason
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Identifiers
| code_info | UDI: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1082-2024%22
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