Medline and Centurion medical convenience kits — Class II medical device recall Z-2045-2026
Ongoing recall by Medline Industries, LP, reported 2026-05-06, distributed nationwide. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal
| Recall number | Z-2045-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-03-16 |
| Classified | 2026-04-30 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 17,550 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00653160091427, 00653160126938, 00653160264968, 00653160280104, 00653160290660, 00653160304732, 00653160327939, 00653160355727, 10193489195453, 10653160126935, 10653160264965, 10653160280101, 10653160290667, 10653160304739, 10653160327936, 10653160355724, 10888277781276, 10888277781320, 20193489195450, 40888277781277, 40888277781321, 50653160091422 |
| Lot numbers | 2025100890, 2025101090, 2025103190, 2025110590, 2025110790, 2025111990, 2025112490, 2025120990, 2025121990, 2026010690, 2026011390, 2026020690, 2026020990, 2026021090, 2026021290, 2026021790 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2045-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.