FDA Recall of Medline Medical Kits Due to Non-Sterile Alcohol Prep Pads

Source: FDA · United States

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Medline Industries is recalling 4050 kits of blood culture and blood draw kits because they contain non-sterile alcohol prep pads contaminated during a routine audit.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline Industries, LP is recalling specific medical convenience kits that contain Webcol Large Alcohol Prep Pads, which were found to be non-sterile due to the presence of a contaminant (Paenibacillus phoenicis) discovered in a routine sterilization dose audit.

Which Products Are Affected

The affected products are:

  • BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520, with UDI/DI each 10193489197679, UDI/DI case 20193489197676, and Lot Numbers: 2025101301 and 2025113001.
  • BLOOD DRAW KIT, Medline Kit SKU EBSI1317, with UDI/DI each 10193489195804, UDI/DI case 20193489195801, and Lot Numbers: 2025120390 and 2026022390. A total of 4050 kits are affected, distributed nationwide in the United States. The official recall number is Z-2040-2026.

What You Should Do

Consumers who have these products should follow the initial firm notifications, which may include email, fax, letter, press release, telephone, or a visit, as initiated by Medline Industries, LP. Stop using the affected kits and contact the firm for further instructions on returns or refunds.

Why This Matters

This recall ensures the safety of medical devices by addressing potential risks from non-sterile products, which could lead to health issues in a clinical setting.

Source

FDA recall notice Z-2040-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 4050 kits of blood culture and blood draw kits because they contain non-sterile alcohol prep pads contaminated during a routine audit.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.