Medline Convenience Kits Recall Issued by FDA

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 5,698 convenience kits containing recalled Huons Lidocaine ampules due to quality issues identified during an FDA inspection.

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

This notice was issued by FDA on August 7, 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 initiated a voluntary recall of certain convenience kits because they contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules subject to a separate recall by Huons Co., Ltd. for quality issues identified during a recent FDA manufacturing inspection.

Which Products Are Affected

The recall covers 5,698 kits distributed nationwide in the United States with the following details:

  • ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145, UDI-DI: 10653160349259 (each), 00653160349252 (case), Lot Number: 2025120590
  • Universal Central/Art Line Insertion Kit, Model Number: ART155A, UDI-DI: 10653160316459 (each), 00653160316452 (case), Lot Number: 2025100890
  • ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B, UDI-DI: 10653160353577 (each), 00653160353570 (case), Lot Number: 2025091590

Recall Number: Z-2533-2026. Classification: Class II. Event ID: 99162.

What You Should Do

Consumers and healthcare facilities should stop using the affected kits and follow instructions provided in the recall notification from Medline Industries, LP.

Why This Matters

The recall involves medical device kits used for arterial and central line access that contain lidocaine ampules flagged for potential quality issues.

Source

FDA Enforcement Report, recall number Z-2533-2026, event ID 99162.

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 is recalling 5,698 convenience kits containing recalled Huons Lidocaine ampules due to quality issues identified during an FDA inspection.
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 severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
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.