Medline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing Webcol Large Alcohol Prep Pads because the pads were found to be non-sterile due to contamination with Paenibacillus phoenicis bacteria discovered during a sterilization audit.
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 an FDA Class II recall of sterile medical device components (alcohol prep pads) that were found to be non-sterile due to bacterial contamination. Non-sterile medical supplies used in central line insertion carry risk of serious infection, and the source text does not report any illnesses or injuries, placing this at score 3 under the rubric criterion for high-risk contamination without reported illness.
Plain-English summary
Medline Industries, LP is recalling specific lots of Centurion medical convenience kits labeled as Universal Central/Art Line Insertion Kit (SKU ART155A) that contain Webcol Large Alcohol Prep Pads. Cardinal Health determined the alcohol prep pads are non-sterile following discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit.
The affected kits were distributed nationwide across the United States. The recalled product carries specific lot numbers: 2025100890 and 2026011290.
Consumers in healthcare settings should not use the affected kits and should contact Medline Industries for guidance on return or replacement of the recalled products.
For more information, healthcare providers should reference FDA recall number Z-2039-2026.
The recalled product
- Product
- Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
- Manufacturer
- Medline Industries, LP
- Affected units
- 120
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 (4)
- UDI/DI each 10653160316459
- UDI/DI case 00653160316452
- Lot Numbers: 2025100890
- 2026011290.
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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