Z-2040-2026 Class II Ongoing
FDA device recall Z-2040-2026 was initiated by Medline Industries, LP on March 16, 2026 and is designated Class II. 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 Pr… The recall status is ongoing. Affected quantity: 4050 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- March 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4050 kits
Product Description
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679, UDI/DI case 20193489197676, Lot Number : 2025101301; Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679, UDI/DI case 20193489197676, Lot Number : 2025113001; Medline Kit SKU EBSI1317: UDI/DI each 10193489195804, UDI/DI case 20193489195801, Lot Number : 2025120390; Medline Kit SKU EBSI1317: UDI/DI each 10193489195804, UDI/DI case 20193489195801, Lot Number : 2026022390.