RecallRadar

FDA Device recall Z-2041-2026

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU U…

On 2026-05-06 the FDA classified a Class II recall of Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU U… 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

AgencyFDA Device
Recall numberZ-2041-2026
ClassificationClass II
Statusongoing
Initiated2026-03-16
Published2026-05-06
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 5. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 6. IV START KIT, Medline Kit SKU DYNDV2520; 7. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 8. (Centurion) ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 9. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 10. CVAD DRESSING CHANGE KIT, Medline Kit SKU EBSI1364A.

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 UROT1044: UDI/DI each 10889942873890, UDI/DI case 40889942873891, Lot Number: 26BBC230; Medline Kit S…Medline Kit SKU UROT1044: UDI/DI each 10889942873890, UDI/DI case 40889942873891, Lot Number: 26BBC230; Medline Kit SKU IV8770: UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2025101090; Medline Kit SKU DYNDV2520: UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2025112090; Medline Kit SKU ART255: UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2025111890; Medline Kit SKU DYNDC2969: UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2025120190; Medline Kit SKU DYNDV2520: UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2026010290; Medline Kit SKU IV8770: UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2026010790; Medline Kit SKU ART255: UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2026012090; Medline Kit SKU DYNDC2969: UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2026012390; Medline Kit SKU EBSI1364A: UDI/DI

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-2041-2026%22

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