Medline MAJOR HEAD AND NECK PPS Kits Recall Over Potentially Contaminated Component

Source: FDA · United States

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 24 convenience kits due to a potentially contaminated component.

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

This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Kits contain a potentially contaminated component which were recalled by the manufacturer", distributed us nationwide distribution in the states of al, ca, fl, il, ks, la, ma, md, mo, ms, mt, nv, ny, oh, ok, sc, tx, wi.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. 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 is recalling convenience kits because they contain a potentially contaminated component which were recalled by the manufacturer.

Which Products Are Affected

The recall affects Medline convenience kits labeled as MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S. A total of 24 kits are affected, distributed nationwide in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI. The kits have UDI/DI 10198459312557 (each) and 40198459312558 (case), with Lot Number 25LLA853. The FDA recall number is Z-3021-2026.

What You Should Do

Consumers should follow instructions provided by Medline Industries, LP regarding the recalled kits.

Why This Matters

This Class II recall involves devices that may cause temporary or medically reversible adverse health consequences.

Source

FDA recall Z-3021-2026

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 24 convenience kits due to a potentially contaminated component.
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 is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Kits contain a potentially contaminated component which were recalled by the manufacturer" as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
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.