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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmNovember 26, 2025
Date PostedJanuary 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1058-2026
Recall Event ID 98154
Product Classification Patient personal hygiene kit - Product Code NSB
ProductMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Code Information Medline kit SKU DYKS1339B, UDI/DI 10195327386726(EA) 40195327386727 (CS) , Lot Number 25HMC849; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25IMG807; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25JMF937; Medline kit SKU DYKS1359B, UDI/DI 10195327566449(EA) 40195327566440 (CS) , Lot Number 25JMD518; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25HMD322; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25JMG543.
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedline issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue potential risk to the patient, and referred the consignee to the attached B Braun notice for further instructions. The B Braun notice provide "Interim Measures for Users" to provide for the continued use of the product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce1725 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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.
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