Class 2 Device Recall Medline convenience kits

• Date Initiated by Firm: September 24, 2026
• Date Posted: November 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0417-2027
• Recall Event ID: 100112
• 510(K)Number: K213481
• Product Classification: General surgery tray - Product Code LRO
• Product: Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ROBOTIC COLON DYNJ911424 ROBOTIC LITHOTOMY DYNJ903440D ROBOTIC THORACOSCOPY DYNJ910924A RR-LAP DONOR NEP ACCESSORY DYNJ63395D ABDOHYST LAPAEXPL DYNJ910659A C SECTION PACK DYNJ66873C C-SECTION DYNJ911236 DAVINCI GYN PACK DYNJ69169F GENERAL ROBOTIC PACK DYNJ62659F DYNJ62659G GYN/PROSTATE ROBOTIC PACK DYNJ62594D LAPAROTOMY DYNJ911243 LAVH DYNJ87680A OPEN HEART A&B DYNJ911245 PCNL BTGH DYNJT7376 SHELBY ABDOMINAL-UNIVERSAL PK DYNJ62669D SLUH CRANIOTOMY PACK-LF DYNJ0369348T UCSD ACOUSTIC NEUROMA PACK DYNJ59953L
• Code Information: DYNJ911424 UDI-DI 10198459341267 Lot 26FMH166 DYNJ903440D UDI-DI 10195327407681 Lot 26ABH105 DYNJ910924A UDI-DI 10198459529047 Lot 26EBC703 DYNJ63395D UDI-DI 10198459783821 Lot 26ELA432 DYNJ910659A UDI-DI 10198459479625 Lot 26BBQ818 DYNJ66873C UDI-DI 10198459511592 Lot 25LBT825 DYNJ911236 UDI-DI 10198459302299 Lot 26ABN933 DYNJ69169F UDI-DI 10198459268793 Lot 26EMB812 DYNJ62659F UDI-DI 10198459174582 Lot 25LBK659 DYNJ62659G UDI-DI 10198459665257 Lot 26ABR665 DYNJ62594D UDI-DI 10198459049767 Lot 25LBJ493 DYNJ911243 UDI-DI 10198459302329 Lots 25KBE169 25LBC079 DYNJ87680A UDI-DI 10198459511028 Lot 26BMD495 DYNJ911245 UDI-DI 10198459302336 Lots 25KBE458 25KBH205 25LBA067 25LBI505 DYNJT7376 UDI-DI 10198459625541 Lot 26BBL872 DYNJ62669D UDI-DI 10198459744792 Lot 26DBD898 DYNJ0369348T UDI-DI 10198459733826 Lot 26FBM787 DYNJ59953L UDI-DI 10198459695803 Lot 26DLA957
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 800-633-5463
• Manufacturer Reason for Recall: Convenience kits contain additional product codes and lots of recalled CliniClean Pericare Wipes identified by manufacturer. Wipes may be contaminated with a lubricant used in the manufacturing process. Use of affected wipes may cause localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare may increase the risk of localized infection or catheter-associated urinary tract infection.
• FDA Determined Cause: Process change control
• Action: This is an update to a previously issued letter due to the manufacturer/supplier identifying additional lots of affected product. On September 24, 2026, customers were notified of the additional products and lots affected. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a sticker indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
• Quantity in Commerce: 7,043 kits
• Distribution: US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IN, LA, MA, MN, MO, MS, MT, NC, NE, NV, NY, OH, OK, RI, SC, TN, TX, WI.
• 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