Class 1 Device Recall A M S, ALIGNED MEDICAL SOLUTIONS surgical convenience kit

• Date Initiated by Firm: May 21, 2026
• Date Posted: July 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2619-2026
• Recall Event ID: 99189
• Product Classification: General surgery tray - Product Code LRO
• Product: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
• Code Information: UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
• FEI Number: 1000125955
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: Field Corrective Action; 406-259-6387
• Manufacturer Reason for Recall: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
• FDA Determined Cause: Material/Component Contamination
• Action: AMS ALIGNED MEDICAL SOLUTIONS issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/21/2026 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 CARDINAL HEALTH announced the recall of 5110 Webcol" Large Alcohol Prep Pad 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 Cardinal Alcohol Prep Pad should be identified and set aside. " The recalled Cardinal Alcohol Prep Pad 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." For questions or concerns: fieldcorrectiveaction@alignedmedicalsolutions.com.
• Quantity in Commerce: 1080 kits
• Distribution: US Nationwide distribution in the states of PA, GA, CA, 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.