Medline Kits Recall Due to Bupivacaine 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 28,106 kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP due to quality issues with the anesthetic component.

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

This notice was issued by FDA on June 23, 2026 and geographically references United States. Its severity classification of "high" 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline Industries, LP initiated a voluntary recall of kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP. The component was recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. The recall is classified as Class I by the FDA and remains ongoing.

Which Products Are Affected

The recall affects 28,106 Medline kits distributed nationwide in the US, US Virgin Islands, and the countries of Bahamas, Panama, and Barbados. Affected products include 52 Medline Kit SKUs such as DYNJRA1555, DYNJRA1817, DYNJRA1920, DYNJRA2013, DYNJRA2017, DYNJRA2067, DYNJRA2067A, DYNJRA2093, DYNJRA2117A, DYNJRA2124, DYNJRA2124A, DYNJRA2144, DYNJRA2221, DYNJRA2333, DYNJRA2390, DYNJRA2402, DYNJRA2407, DYNJRA2407A, DYNJRA2407B, DYNJRA2447, DYNJRA2447A, DYNJRA2488A, DYNJRA2545, DYNJRA2549, DYNJRA2550, DYNJRA2552, DYNJRA2554, DYNJRA2554A, DYNJRA2578, DYNJRA2588, DYNJRA2602, DYNJRA2618, DYNJRA2619, DYNJRA2622, DYNJRA2624, DYNJRA2631, DYNJRA2632, DYNJRA2633, DYNJRA2645, DYNJRA2654, DYNJRA2665, DYNJRA2667, DYNJRA2675, DYNJRA2680, DYNJRA2682, DYNJRA2684, DYNJRA2725, DYNJRA2757, DYNJRA9039, DYNJRA9045, PAIN2333, and SAMPA0135. Specific lot numbers and UDI/DI codes are listed in the FDA recall notice Z-2232-2026.

What You Should Do

Consumers and healthcare facilities should immediately stop using the affected kits and follow instructions provided by Medline Industries for returns or further guidance. Contact Medline for return and refund information.

Why This Matters

This Class I recall involves a serious risk to patient safety from potentially ineffective or contaminated anesthetic used in spinal and nerve block procedures.

Source

FDA Recall Number Z-2232-2026; https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 28,106 kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP due to quality issues with the anesthetic 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 severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
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.