Aligned Medical Solutions — Class I medical device recall Z-1080-2024
Ongoing recall by Windstone Medical Packaging, Inc., reported 2024-02-28, distributed in CA, FL, IL. Sterility assurance for saline included in surgical kits cannot be guaranteed.
| Recall number | Z-1080-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2023-12-22 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | CA, FL, IL |
| Quantity | 128 kits |
| Reason classes | sterility |
| Lot numbers | 192436, 192774, 196582 |
Product
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Reason for recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1080-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.