Medline Convenience Kits Recall Due to Potential Contamination

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, LP is recalling 241 convenience kits nationwide because they contain a potentially contaminated component.

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

This notice was issued by FDA on September 8, 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, Devices.

What Happened

Medline Industries, LP initiated a voluntary recall of certain convenience kits after determining they contain a potentially contaminated component that was recalled by the manufacturer.

Which Products Are Affected

The recall covers 241 kits distributed nationwide in AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI. Affected products include:

  • LAMI FUSION, Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Numbers 25LMF531 and 25JML577
  • NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104, UDI/DI 10198459539374 (each) 40198459539375 (case), Lot Number 25JBM473
  • CRANIOTOMY, Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Numbers 26DDB085, 26DDA481, and 26CDA102
  • KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K, UDI/DI 10198459419614 (each) 40198459419615 (case), Lot Number 25KLA074

Recall number Z-3029-2026. Classification: Class II. Recall initiation date: July 10, 2026.

What You Should Do

Consumers should verify product lot numbers against the listed SKUs and contact Medline Industries, LP regarding the recalled kits.

Why This Matters

The recall involves medical device kits distributed across multiple U.S. states.

Source

FDA recall Z-3029-2026

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 241 convenience kits nationwide because they contain 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.