Medline Convenience Kits Recall (Jul 10, 2026)

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 419 convenience kits distributed nationwide because they contain a potentially contaminated component.

Reading this FDA recall beyond the headline

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.

A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a 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 initiated a voluntary recall of certain convenience kits after determining that the kits contain a potentially contaminated component which were recalled by the manufacturer. The recall is classified as Class II by the FDA and remains ongoing.

Which Products Are Affected

The following Medline convenience kits are affected, totaling 419 kits distributed to states including AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI:

  • CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986
  • EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434
  • GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Numbers 26BBA665, 25KBR602, 25JBH531
  • UNIVERSAL GYN, Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Numbers 25KBL876, 25JBS218 Recall number Z-3028-2026. Recall initiation date: July 10, 2026.

What You Should Do

Consumers in possession of the affected kits should follow instructions provided by Medline Industries, LP regarding the recall.

Why This Matters

The recall affects medical procedure kits used in surgical settings across multiple states due to a potential contamination risk in a component.

Source

FDA recall Z-3028-2026, report date September 2, 2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Similar notices nationwide by length or severity timing 8

Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

Questions & Answers

Questions readers often have about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 419 convenience kits distributed 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.