Class 2 Device Recall AMS16835 Fluids Kit RX

• Date Initiated by Firm: April 27, 2026
• Date Posted: June 03, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2307-2026
• Recall Event ID: 98957
• Product Classification: General surgery tray - Product Code LRO
• Product: Aligned Medical AMS16835 Fluids Kit RX
• Code Information: UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
• FEI Number: 1000125955
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• Manufacturer Reason for Recall: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT: MEDICAL DEVICE RECALL dated 4/27/26 was sent to customers. Please Note: Since AMS manufactured convenience kits that contain Huons Co. Ltd. Pharmacy Lidocaine HCL 1% 5ML SDV, we are extending our recall strategy to the end user level. 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 Huons Co. Ltd. announced the recall of 73293-0001-2 Lidocaine Hydrochloride Injection 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 Huons Co. Ltd. Lidocaine Hydrochloride Injection should be identified, and quarantined. " The recalled Huons Co. Ltd. Lidocaine Hydrochloride Injection should be rendered unusable to protect against inadvertent use and returned to AMS. 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 Huons Co. Ltd. product is needed. If you have any questions or concerns please do not hesitate to contact us at fieldcorrectiveaction@alignedmedicalsolutions.com. Dear Customer, This letter is to describe the process for placing the "Recall Notice
• Quantity in Commerce: 875 kits
• Distribution: US Nationwide distribution in the states of IL, VA.
• 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.