Medline Convenience Kits Recall

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 40 convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA inspection of the drug manufacturer.

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, Devices.

What Happened

Medline Industries, LP initiated a voluntary recall of certain convenience kits after a recall notice was issued by Huons Co., Ltd. for the Lidocaine Ampules included in the kits. The action stems from quality issues identified during a recent FDA manufacturing inspection of the drug manufacturing site. The recall is classified as Class II and remains ongoing.

Which Products Are Affected

The recall affects the following Medline Convenience Kits distributed nationwide in the United States:

  • IMAGING BIOPSY TRAY, Model Number: DYNDH1068, UDI-DI: 10889942172122 (each), 40889942172123 (case), Lot Number: 2025101090
  • BREAST BIOPSY PACK, Model Number: PHS234706I, UDI-DI: 10198459330278 (each), 40198459330279 (case), Lot Number: 25JLB029 A total of 40 kits are involved. The FDA recall number is Z-2539-2026.

What You Should Do

Consumers should stop using the affected kits. Contact information for returns or further instructions has not been specified in the recall notice.

Why This Matters

This Class II recall involves devices containing a drug component subject to quality concerns that could lead to temporary or reversible adverse health consequences.

Source

FDA recall Z-2539-2026, report date 20260708.

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 40 convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA inspection of the drug manufacturer.
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.