Medline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing non-sterile Webcol Large Alcohol Prep Pads due to discovery of Paenibacillus phoenicis contamination. Affected kits were distributed nationwide.
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 recall involves FDA Class II medical devices with a high-risk pathogen (Paenibacillus contamination in sterile products used in invasive procedures). The source explicitly states no illnesses or injuries have been reported, but the hazard—non-sterile components in medical convenience kits—poses risk of harm in clinical use, warranting a High severity score.
Plain-English summary
Medline Industries, LP is recalling specific lot numbers of Medline and Centurion medical convenience kits that contain Cardinal Health Webcol Large Alcohol Prep Pads. The recalled kits include: Foley Care Kit (SKU UROT1044), IV Start Kit with Extension Tubing (SKU IV8770), IV Start Kit (SKU DYNDV2520), Arterial Line Bundle (SKU ART255), On/Off Tray (SKU DYNDC2969), and CVAD Dressing Change Kit (SKU EBSI1364A). A total of 40,845 kits have been distributed nationwide.
The recall was initiated after Cardinal Health discovered that Webcol Large Alcohol Prep Pads in these kits are non-sterile following the discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit. Non-sterile alcohol prep pads used in medical procedures could pose a risk of contamination.
Patients and healthcare facilities using these kits should stop use immediately and contact Medline Industries for product returns or replacements. Specific lot numbers and UDI codes are available through the FDA recall database. Healthcare providers should verify lot numbers against the recalled products before use.
The recalled product
- Product
- Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL…
- Manufacturer
- Medline Industries, LP
- Affected units
- 40,845
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 (20)
- Medline Kit SKU UROT1044: UDI/DI each 10889942873890
- UDI/DI case 40889942873891
- Lot Number: 26BBC230
- Medline Kit SKU IV8770: UDI/DI each 10653160382638
- UDI/DI case 00653160382631
- Lot Number: 2025101090
- Medline Kit SKU DYNDV2520: UDI/DI each 10653160384045
- UDI/DI case 00653160384048
- Lot Number: 2025112090
- Medline Kit SKU ART255: UDI/DI each 10653160367598
- UDI/DI case 00653160367591
- Lot Number: 2025111890
- Medline Kit SKU DYNDC2969: UDI/DI each 10653160376071
- UDI/DI case 00653160376074
- Lot Number: 2025120190
- Lot Number: 2026010290
- Lot Number: 2026010790
- Lot Number: 2026012090
- Lot Number: 2026012390
- Medline Kit SKU EBSI1364A: UDI/DI each 10653160363163
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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