FDA Device recall Z-1079-2024
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, 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, Local Lower Extremity Pack I, AMS10833, 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-1079-2024 |
| 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, Local Lower Extremity Pack I, AMS10833, STERILEEO
Reason
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Identifiers
| code_info | DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137…DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297 |
|---|
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-1079-2024%22
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