Medline Circumcision Trays Recall Due to Lidocaine Quality Issues

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 512 convenience kits containing recalled Huons Lidocaine ampules distributed nationwide.

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

This notice was issued by FDA on August 8, 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. due to quality issues identified during an FDA manufacturing inspection.

Which Products Are Affected

The recall covers 512 kits distributed nationwide with the following products and lot numbers:

  • MERCY MEDICAL CIRCUMCISION TRAY (Model CIT6780, UDI-DI 10653160324232 each / 00653160324235 case), Lot 2025102790
  • CIRCUMCISION TRAY W/1.1CM CIRCLAMP (Model CIT3225A, UDI-DI 00653160165142 each / 10653160165149 case), Lot 2025102190
  • CIRCUMCISION TRAY (Model CIT6325, UDI-DI 10653160294160 each / 00653160294163 case), Lot 2025102390

Recall number Z-2546-2026, Class II, initiated May 21, 2026.

What You Should Do

Consumers in possession of the affected kits should verify the lot numbers and follow instructions provided in the recall notice from the recalling firm.

Why This Matters

The nationwide recall involves medical kits used in procedures and addresses potential quality concerns with a component drug product.

Source

FDA Recall Z-2546-2026 - Medline Industries, LP, Northfield, IL

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 512 convenience kits containing recalled Huons Lidocaine ampules distributed nationwide.
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.