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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Centurion

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 Class 2 Device Recall Medline Centurionsee related information
Date Initiated by FirmMarch 16, 2026
Date PostedApril 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2045-2026
Recall Event ID 98692
Product Classification Dressing change tray - Product Code OXQ
ProductMedline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B; 4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B; 5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A; 6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A; 7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810; 8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100; 9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340; 10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660; 11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.
Code Information Medline Kit SKU DT17360: UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025101090; Medline Kit SKU IVS1975A: UDI/DI each 10653160327936, UDI/DI case 00653160327939, Lot Number: 2025100890; Medline Kit SKU DT5565B: UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2025103190; Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2025110590; Medline Kit SKU DT17360: UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025110790; Medline Kit SKU EBSI1171A: UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2025111990; Medline Kit SKU EBSI1173A: UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2025112490; Medline Kit SKU DM810: UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2025120990; Medline Kit SKU DM100: UDI/DI each 10653160280101, UDI/DI case 00653160280104, Lot Number: 2026010690; Medline Kit SKU DT5565B: UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2026011390; Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2026011390; Medline Kit SKU DT7340: UDI/DI each 00653160091427, UDI/DI case 50653160091422, Lot Number: 2026021090; Medline Kit SKU DM660: UDI/DI each 10653160290667, UDI/DI case 00653160290660, Lot Number: 2026020690; Medline Kit SKU DM810: UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2026020990; Medline Kit SKU EBSI1171A: UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2026021290; Medline Kit SKU EBSI1173A: UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2026021790; Medline Kit SKU EBSI1365A: UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2025121990; Medline Kit SKU EBSI1365A: UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2026020990.
FEI Number 1417592
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 Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/16/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the affected product be quarantined pending additional labeling. Consignees were directed to respond to the notice via Website link: https://recalls.medline.com, and upon receipt of the submitted response form, the account will receive over-labels to place on affected inventory, with instructions for the user to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight. Distributors or those who have further distributed the product are directed to notify those receiving the affected kits, and to include the customers quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to the customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce17550 kits
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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