Medline Industries, LP recalls Medline and Centurion medical convenience kits
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Lot #
- 2025101090; Medline Kit SKU IVS1975A: UDI/DI each 10653160327936, UDI/DI case 00653160327939
- Lot #
- 2025100890; Medline Kit SKU DT5565B: UDI/DI each 00653160126938, UDI/DI case 10653160126935
- Lot #
- 2025103190; Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453, UDI/DI case 20193489195450
- Lot #
- 2025110590; Medline Kit SKU DT17360: UDI/DI each 10653160264965, UDI/DI case 00653160264968
- Lot #
- 2025110790; Medline Kit SKU EBSI1171A: UDI/DI each 10888277781276, UDI/DI case 40888277781277
- Lot #
- 2025111990; Medline Kit SKU EBSI1173A: UDI/DI each 10888277781320, UDI/DI case 40888277781321
- Lot #
- 2025112490; Medline Kit SKU DM810: UDI/DI each 10653160304739, UDI/DI case 00653160304732
- Lot #
- 2025120990; Medline Kit SKU DM100: UDI/DI each 10653160280101, UDI/DI case 00653160280104
- Lot #
- 2026010690; Medline Kit SKU DT5565B: UDI/DI each 00653160126938, UDI/DI case 10653160126935
- Lot #
- 2026011390; Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453, UDI/DI case 20193489195450
- Lot #
- 2026011390; Medline Kit SKU DT7340: UDI/DI each 00653160091427, UDI/DI case 50653160091422
- Lot #
- 2026021090; Medline Kit SKU DM660: UDI/DI each 10653160290667, UDI/DI case 00653160290660
- Lot #
- 2026020690; Medline Kit SKU DM810: UDI/DI each 10653160304739, UDI/DI case 00653160304732
- Lot #
- 2026020990; Medline Kit SKU EBSI1171A: UDI/DI each 10888277781276, UDI/DI case 40888277781277
- Lot #
- 2026021290; Medline Kit SKU EBSI1173A: UDI/DI each 10888277781320, UDI/DI case 40888277781321
- Lot #
- 2026021790; Medline Kit SKU EBSI1365A: UDI/DI each 10653160355724, UDI/DI case 00653160355727
- Lot #
- 2025121990; Medline Kit SKU EBSI1365A: UDI/DI each 10653160355724, UDI/DI case 00653160355727
- Lot #
- 2026020990
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What the firm is doing
Medline 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.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2045-2026
- FDA device classification · OXQOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5075The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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