Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Aligned Medical Solutions Recalled by Windstone Medical Packaging, Inc. Due to Sterility assurance for saline included in surgical kits...

Date: December 22, 2023
Company: Windstone Medical Packaging, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Windstone Medical Packaging, Inc. directly.

Affected Products

Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

Quantity: 128 kits

Why Was This Recalled?

Sterility assurance for saline included in surgical kits cannot be guaranteed.

Where Was This Sold?

This product was distributed to 3 states: CA, FL, IL

Affected (3 states)Not affected

About Windstone Medical Packaging, Inc.

Windstone Medical Packaging, Inc. has 315 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report