Z-2040-2026Class II
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-03-16 / Open, Classified / root cause: sterility
Medline Industries, LP began a recall of Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT... on . 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 , the recall status on record is Open, Classified, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-2040-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- 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.
- Product code
- OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
- 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
- 4050 kits
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2039-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2040-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2041-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2042-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2043-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2044-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2045-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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