Medline Centurion Medical Convenience Kits Recalled for Non-Sterility
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads due to discovery of non-sterile product contaminated with Paenibacillus phoenicis bacteria 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: The source identifies this as FDA Class II recall. The hazard is non-sterile medical device product (alcohol prep pads) with confirmed bacterial contamination, a pathogenic organism risk that meets the High threshold for medical devices with risk-of-harm potential. No reported illnesses or injuries are mentioned in the source text.
Plain-English summary
Medline Industries, LP is recalling Centurion medical convenience kits (SKU 75670, labeled as "LATEX FREE GENERAL PURPOSE TRAY") that contain Webcol Large Alcohol Prep Pads. Cardinal Health discovered the alcohol prep pads to be non-sterile following routine sterilization dose auditing that identified Paenibacillus phoenicis contamination.
The affected product (Lot Number 2025102290) was distributed nationwide across the United States. The recall impacts approximately 1,590 kits identified by the case-level UDI/DI 10653160095897.
Patients and healthcare providers who have received or are using these kits should discontinue use immediately. Healthcare facilities should quarantine remaining inventory and contact Medline Industries or Cardinal Health regarding return or replacement instructions.
The recalled product
- Product
- Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,590
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 00653160095890
- UDI/DI case 10653160095897
- Lot Number: 2025102290
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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