Recall archive / FDA device enforcement
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO — FDA record Z-1081-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
- Reason
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Classification
- Class I
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 80 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1081-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: B098AMS129470/ Lot #s: 192389 and 194805 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: FL, IL, CA OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 28, 2024
- Recall initiation date
- Dec 22, 2023
- Center classification date
- Feb 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.