FDA Recall of Medline Medical Kits Due to Non-Sterile Alcohol Prep Pads
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,301 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.