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Recall Observatory FDA recall evidence

Device product

Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395

Z-2044-2026

March 16, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98692
Status
Ongoing
Classification
Class II
Quantity
432 kits
Official record key
device-enforcement:Z-2044-2026

Official wording

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.

Code information: UDI/DI each 10653160280644, UDI/DI case 00653160280647. Lot Numbers: 2025102090, 2026010990.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.