FDAClass II · Medical device · Recalled May 6, 2026

Medline and Centurion medical convenience kits recall — Medline Industries, LP

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2045-2026
Brand: Medline Industries
Classification: Class II
Units affected: 17550 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline 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.

Affected products

Medline and Centurion medical convenience kits

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Distribution: US Nationwide distribution.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98692
Recall initiated: March 16, 2026
FDA classified: April 30, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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