Lower riskMedical device recall · FDA · Published December 22, 2023
Windstone Medical Ocular Pack Recall: Sterility Risk in Surgical Kits
Windstone Medical recalls sterile ocular packs AMS12947 STERILEEO due to potential sterility issues in surgical kits. Affected lots 192389 and 194805 may not be sterile, risking infection during procedures.
“Windstone Medical Ocular Pack Recall: Sterility Risk in Surgical Kits.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56476-windstone-medical-ocular-pack-recall-sterility-risk-in-surgical-kits. Based on FDA recall #Z-1081-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1081-2024%22&limit=1).
The FDA announced on Dec. 22, 2023, that Windstone Medical Packaging is recalling Aligned Medical Solutions In House Ocular Packs due to sterility assurance risks for included saline. The firm initiated this voluntary Class I recall affecting 80 kits distributed in Florida, Illinois, and California.
How to tell if you have it
Brand: Windstone Medical
Product: Aligned Medical Solutions, In House Ocular Pack
Model/Part Number: AMS12947, STERILEEO
Lot Codes: 192389 and 194805
Quantity: 80 kits
The hazard
The recall addresses the inability to guarantee sterility assurance for saline included in the surgical kits. The FDA classified this as a Class I recall, indicating a high risk of serious adverse health consequences.
Context
GovInfoNow's records show Windstone Medical Packaging has had 14 other recalls since Oct. 24, 2017. Recent brand issues include July 29, 2026, kits with blue break-off parts and June 17, 2026, kits involving lidocaine injection risks. Other recent recalls of similar products include Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (Jan. 7, 2026) and Medical Action Industries Epidural Kits Recall: Compromised Sterility Risk (July 23, 2026).
How to tell if you have this one
Check for the model AMS12947 STERILEEO with lot numbers 192389 or 194805. The product is sold under Windstone Medical Packaging, Inc.
Brand
Windstone Medical
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1081-2024 (December 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1081-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.