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-0418-2027
• Recall Event ID: 100112
• Product Classification: Gynecological laparoscopic kit - Product Code OHD
• Product: Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes DAVINCI DYNJ906763C GYN ABDOMINAL ONCOLOGY DYNJ911414A GYN LAPAROSCOPIC PACK DYNJ909394B GYN LAPAROSCOPY DYNJ903449D DYNJ904701J GYN ROBOTIC CDS984076J DYNJ910181A DYNJ910181C GYN ROBOTIC ADD ON PACK DYNJ43837D OH GYN/LAP ROBOT PACK DYNJ89759 ROBOT ME RF DYNJ900203N ROBOTIC DYNJ903485K ROBOTIC COLON CDS CDS984953J ROBOTIC GU/GYN CDS983393L CDS983393M ROBOTIC GYN DYNJ905230K SOLK GYN-LAP ROBOT PACK DYNJT10414 W&I ROBOT DYNJ910664A WPH GYN LAPAROSCOPY PACK DYNJ89781 DYNJ89781A
• Code Information: DYNJ906763C UDI-DI 10198459551833 Lots 25LBR121 26CBS290 DYNJ911414A UDI-DI 10198459670428 Lot 26FMI519 DYNJ909394B UDI-DI 10198459556579 Lots 25KBE469 26ABO368 DYNJ903449D UDI-DI 10195327407520 Lot 26CBN427 DYNJ904701J UDI-DI 10198459373060 Lot 26BDA186 CDS984076J UDI-DI 10198459283147 Lots 26CBD748 26DBA124 26DBC215 DYNJ910181A UDI-DI 10198459556586 Lots 25KLA664 26ALA732 26ALA897 DYNJ910181C UDI-DI 10198459780950 Lot 26ELA453 DYNJ43837D UDI-DI 10195327657222 Lot 26EMJ002 DYNJ89759 UDI-DI 10198459289286 Lots 25KBK074 25KBQ997 26ABN671 DYNJ900203N UDI-DI 10198459510144 Lots 26ABX032 26BBC420 26CBS914 DYNJ903485K UDI-DI 10198459255083 Lot 26BDA988 CDS984953J UDI-DI 10198459641367 Lots 26ABP040 26DBB664 CDS983393L UDI-DI 10198459224614 Lots 25LBC619 25LBH230 26ABI772 CDS983393M UDI-DI 10198459641350 Lot 26DBA175 DYNJ905230K UDI-DI 10198459520532 Lots 26CBF509 26CBQ707 DYNJT10414 UDI-DI 10198459792441 Lot 26FBE035 DYNJ910664A UDI-DI 10198459178672 Lot 26ABB917 DYNJ89781 UDI-DI 10198459289521 Lots 25LBR578 26CBK466 DYNJ89781A UDI-DI 10198459794933 Lot 26FBL798
• 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.