CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

Medline medical convenience kits recalled by Medline Industries

Medline Industries is recalling Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as, distributed nationwide in the US. The recall was initiated on 16 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline 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.
Quantity recalled4050 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2040-2026
FDA event ID
98692
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
16 Mar 2026
FDA classified
30 Apr 2026
Reported
6 May 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

16 Mar 2026Recall initiated by company
30 Apr 2026Classified by FDA+45 days
6 May 2026Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 98692
ReportedClassRecallCompanyReasonWhere
CLASS IIMedline and Centurion medical convenience kits recalledMedline IndustriesSterilityNationwide
CLASS IIMedline and Centurion medical convenience kits recalledMedline IndustriesSterilityNationwide
CLASS IIMedline or Centurion medical convenience kits recalledMedline IndustriesSterilityNationwide
CLASS IICenturion medical convenience kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IICenturion medical convenience kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IICenturion medical convenience kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide

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