Medline PPE Kit Recall Issued Over Sterility Assurance
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Medline Industries is recalling 13,025 units of PPE Kits (model DYK1011945P) due to potential sterility issues from equipment calibration problems.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 25, 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, fda, medical-devices.
What Happened
Medline Industries, LP has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Which Products Are Affected
Medline Convenience Kits: PPE KIT, Model Number: DYK1011945P. A total of 13,025 units distributed Worldwide - US Nationwide distribution are affected. The recall covers 44 specific lots with UDI-DI 10884389389973 (each) and 40884389389974 (case): 21BFA109, 21EFA047, 21FFA074, 21GFA025, 21HFA112, 21IFA100, 21JFA039, 21JFA139, 21KFA114, 22BFA066, 22CFA086, 22DFA081, 22IFA036, 22JFA111, 22LFA068, 23AFA049, 23AFA090, 23BFA006, 23BFA124, 23CFA070, 23DFA024, 23EFA007, 23EFA070, 23GFA079, 23HFA039, 23HFA117, 23HFA178, 23IFA139, 23JFA065, 23KFA006, 23KFA054, 23LFA050, 24BFA115, 24FFA115, 24GFA027, 24IFA085, 24JFA035, 24JFA136, 24KFA099, 25CFA033, 25DFA033, 25FFA025, 25GFA099, 25IFA006. This is FDA recall number Z-2104-2026, Class II, initiated January 7, 2026.
What You Should Do
Consumers should verify product lot numbers against the recalled list.
Why This Matters
The calibration issues have the potential to impact the sterility assurance level of the affected PPE kits distributed nationwide.
Source
FDA recall Z-2104-2026. https://www.fda.gov
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 (1,453 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 25, 2026.
Frequently Asked Questions
Common questions about this FDA recall.