Class 2 Device Recall Medline

• Date Initiated by Firm: December 24, 2025
• Date Posted: February 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1330-2026
• Recall Event ID: 98284
• 510(K)Number: K213481
• Product Classification: General surgery tray - Product Code LRO
• Product: 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
• Code Information: 1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888; 2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566; 3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964; 4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178; 5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624; 6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706; 7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742; 8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778; 9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757; 10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300; 11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.
• 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 items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
• FDA Determined Cause: Packaging change control
• Action: Medline issued an URGENT MEDICAL DEVICE recall notice to its consignees on 12/24/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee locate and quarantine the affected units and respond to the notice using the website link: https://recalls.medline.com; Recall Reference #: R-25-257-FGX1, and the specific code listed in the notice. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors and those who further distributed the affected its were directed to notify those to whom the kits were distributed or transferred, and include those quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 21854 units
• Distribution: US Nationwide distribution.
• 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