CLASS I ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
Aligned Medical Solutions, In House Ocular Pack, AMS12947A Sterileeo recalled
Windstone Medical Packaging is recalling Aligned Medical Solutions, In House Ocular Pack, AMS12947A Sterileeo, distributed in California, Florida, Illinois. The recall was initiated on 22 Dec 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1080-2024
- FDA event ID
- 93807
- Recalling firm
- Windstone Medical Packaging, Billings, MT
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 22 Dec 2023
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2023 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +56 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Where it was distributed
US: FL, IL, CA OUS: None
Questions about this recall
Why was it recalled?
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Which lots are affected?
UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582
Where was it sold?
US: FL, IL, CA OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 93807This product is part of a recall event; the main page for the event is Aligned Medical Solutions, In House Ocular Pack, AMS12947, Sterileeo recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Aligned Medical Solutions, In House Ocular Pack, AMS12947, Sterileeo recalled | Windstone Medical Packaging | Sterility | CA, FL, IL | |
| CLASS I | Aligned Medical Solutions, Closure Kit, AMS13043, Sterileeo recalled | Windstone Medical Packaging | Sterility | CA, FL, IL | |
| CLASS I | Aligned Medical Solutions, Local Lower Extremity Pack I recalled | Windstone Medical Packaging | Sterility | CA, FL, IL |
More recalls from Windstone Medical Packaging
All 337| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |