FDA Device recall Z-1081-2024
Aligned Medical Solutions, In House Ocular Pack, AMS12947, 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, In House Ocular Pack, AMS12947, 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-1081-2024 |
| 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, In House Ocular Pack, AMS12947, STERILEEO
Reason
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Identifiers
| code_info | UDI: B098AMS129470/ Lot #s: 192389 and 194805 |
|---|
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-1081-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.