Class 1 Device Recall MEDLINE medical procedure convenience kit

• Date Initiated by Firm: June 08, 2026
• Date Posted: July 23, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2764-2026
• Recall Event ID: 99297
• 510(K)Number: K213481
• Product Classification: General surgery tray - Product Code LRO
• Product: MEDLINE medical procedure convenience kit labeled as: LISTON HIP CDS-LF, Medline kit SKU CDS984556N
• Code Information: UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing ICU Medical, Inc. pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP. ICU Medical, Inc. has been made aware of an urgent medical device recall initiated by Elevaris Medical Devices Inc. for Bupivacaine Hydrochloride in Dextrose Injection ampules due to quality issues, which could result in drug ineffectiveness.
• FDA Determined Cause: Other
• Action: Medline Industries, LP issued an URGENT MEDICAL DEVCIE RECALL notice to its consignees on 6/8/2026 via email and USPS first class mail. The notice explained the issue and requested the following actions be taken: 1. Check stock and quarantine all affected product. 2. Use Website link: https://recalls.medline.com to respond. 3. Once response is received, Medline will send over-labels to affix to affected inventory (if applicable). 4. If the consignee further distributed or transferred the affected product, those to whom the product was sent are to be notified. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 52 kits
• Distribution: US: Mo, CO, IL
• 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.

• 510(K) Database: 510(K)s with Product Code = LRO