Windstone Medical Packaging, Inc. Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Brand
Windstone Medical Packaging, Inc.
Lot Codes / Batch Numbers
UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582
Products Sold
UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582
Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO due to Sterility assurance for saline included in surgical kits cannot be guaranteed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Recommended Action
Per FDA guidance
On January 22, 2024, Windstone Medical Packaging dba Aligned Medical Solutions (AMS) On December 22, 2023, Windstone Medical Packaging dba Aligned Medical Solutions (AMS) issued an "Urgent: Medical Device Recall notice via. E-Mail. AMS asked consignees to take the following actions: 1. Immediately check your inventory for the voluntary recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. 3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to vdavis@alignedmedicalsolutions.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Nurse Assist product is needed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IL
Page updated: Jan 10, 2026