Medline medical convenience kits, containing Webcol Large… recallZ-2040-2026 · Medline Industries, LP · initiated Mar 16, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/16/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the affected product be quarantined pending additional labeling. Consignees were directed to respond to the notice via Website link: https://recalls.medline.com, and upon receipt of the submitted response form, the account will receive over-labels to place on affected inventory, with instructions for the user to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight. Distributors or those who have further distributed the product are directed to notify those receiving the affected kits, and to include the customers quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to the customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-2040-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 16, 2026
- Posted by the FDA
- Apr 30, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 4050 kits
- Product code
- OIB
- Distribution
- US Nationwide distribution.
Product description
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
Code information (models, lots, serial numbers)
Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679, UDI/DI case 20193489197676, Lot Number : 2025101301; Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679, UDI/DI case 20193489197676, Lot Number : 2025113001; Medline Kit SKU EBSI1317: UDI/DI each 10193489195804, UDI/DI case 20193489195801, Lot Number : 2025120390; Medline Kit SKU EBSI1317: UDI/DI each 10193489195804, UDI/DI case 20193489195801, Lot Number : 2026022390.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE EBSI1317Medline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)1 recall0 reports
- MEDLINE DYNDH1520Medline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98692).
- Z-2039-2026 · Open, ClassifiedCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
- Z-2041-2026 · Open, ClassifiedMedline 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 EXTENSIO…
- Z-2042-2026 · Open, ClassifiedCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
- Z-2043-2026 · Open, ClassifiedMedline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECURE…
- Z-2044-2026 · Open, ClassifiedCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
- Z-2045-2026 · Open, ClassifiedMedline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page