Medline Centurion Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads after Cardinal Health determined the pads are non-sterile due to bacterial contamination discovered during sterilization testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall involving non-sterile medical device components contaminated with bacteria (Paenibacillus phoenicis). Although no illnesses or injuries are reported in the source text, non-sterile medical supplies used in dermatological procedures present a risk of infection and adverse health consequences. The bacterial pathogen and sterility failure justify a High severity rating.
Plain-English summary
Medline Industries, LP is recalling specific lots of Centurion medical convenience kits (Medline Kit SKU SK395, labeled as DERMATOLOGY SHAVE KIT) that contain Webcol Large Alcohol Prep Pads. The recall affects 432 kits distributed nationwide.
Cardinal Health determined that the Webcol Large Alcohol Prep Pads are non-sterile following the discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit. The affected lot numbers are 2025102090 and 2026010990.
Consumers who have received these kits should stop using them and contact Medline Industries, LP or their healthcare provider for further instructions regarding safe product disposal or replacement.
The recalled product
- Product
- Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
- Manufacturer
- Medline Industries, LP
- Affected units
- 432
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI each 10653160280644
- UDI/DI case 00653160280647. Lot Numbers: 2025102090
- 2026010990.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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