FDA Device recall Z-2043-2026
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion),…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion),… by Medline Industries, citing 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 We….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2043-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-16 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV8675; 4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12; 5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775; 7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12; 8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 9. IV START KIT, Medline Kit SKU IV8675; 10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775.
Reason
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.
Identifiers
| code_info | Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2025102390; Medline Kit…Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2025102390; Medline Kit SKU IVS1700: UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2025102390; Medline Kit SKU IV8675: UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2025110790; Medline Kit SKU IVSSTK12: UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025111890; Medline Kit SKU IV6940: UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2025112690; Medline Kit SKU IV8775: UDI/DI each 10888277732537, UDI/DI case 20888277732534, Lot Number: 2025120190; Medline Kit SKU IVSSTK12: UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025122690; Medline Kit SKU IVS1700: UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2026010590; Medline Kit SKU IV8675: UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2026010990; Medline Kit SKU IV8310E: UDI/DI each 1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2043-2026%22
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