Class 2 Device Recall AMS ALIGNED MEDICAL SOLUTIONS

• Date Initiated by Firm: June 17, 2026
• Date Posted: July 27, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2812-2026
• Recall Event ID: 99347
• Product Classification: Spinal epidural anesthesia kit - Product Code OFT
• Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
• Code Information: UDI/DI B098AMS13683A0, Lot Number 230451
• FEI Number: 1000125955
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: 406-259-6387
• Manufacturer Reason for Recall: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
• FDA Determined Cause: Material/Component Contamination
• Action: Aligned Medical Solutions (AMS) issues an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 6/17/2026 via email. The notice explained the issue, potential risk, and requested the following: "AMS requests that you undertake the following activities: 1. Immediately check your inventory for the 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. Packs will be labeled with a sticker attached to each pack. This sticker will read: 'RECALL NOTICE ELEVARIS announced the recall of Lidocaine 5mL Ampules contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. " At the time the kit is opened for use any Elevaris Lidocaine 5mL Ampule(s) should be identified and set aside. " The recalled Elevaris Lidocaine should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.' 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 fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Lidocaine Ampules are needed." for questions or concerns, please do not hesitate to contact us at fieldcorrectiveaction@alignedmedicalsolutions.com.
• Quantity in Commerce: 15 kits
• Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.