Medline Convenience Kits Recall Due to Lidocaine Quality Issues
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 510 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 6, 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 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 510 kits distributed nationwide under these products:
- STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C, UDI-DI: 10653160339748 (each), 00653160339741 (case), Lot Number: 2025102290
- STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C, UDI-DI: 10653160339687 (each), 00653160339680 (case), Lot Number: 2025093090
Recall number Z-2538-2026, Class II, initiated May 21, 2026.
What You Should Do
Consumers in possession of the affected kits should contact Medline Industries, LP for further instructions regarding the recall.
Why This Matters
The recall affects 510 kits distributed across the United States and stems from quality concerns with a component drug product.
Source
FDA recall Z-2538-2026; https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (1,092 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.