Z-2041-2026Class II

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1...

Name: Z-2041-2026 Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1...
Creator: Medline Industries, LP
Published: 2026-03-16
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-03-16 / Open, Classified / root cause: sterility

FDA source

Medline Industries, LP began a recall of 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... on 2026-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2041-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-16
Posted: 2026-04-30
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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 LINE BUNDLE, Medline Kit SKU ART255; 5. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 6. IV START KIT, Medline Kit SKU DYNDV2520; 7. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 8. (Centurion) ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 9. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 10. CVAD DRESSING CHANGE KIT, Medline Kit SKU EBSI1364A.
Product code: LRO General Surgery Tray
Reason for recall: 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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 40845 kits
Distribution: US Nationwide distribution.
Product codes and lots: 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; Medline Kit SKU DYNDV2520: UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2026010290; Medline Kit SKU IV8770: UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2026010790; Medline Kit SKU ART255: UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2026012090; Medline Kit SKU DYNDC2969: UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2026012390; Medline Kit SKU EBSI1364A: UDI/DI each 10653160363163, UDI/DI case 00653160363166, Lot Number: 2026010690.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2041-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2039-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30
Z-2040-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30
Z-2041-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30
Z-2042-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30
Z-2043-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30
Z-2044-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30
Z-2045-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-30

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)