Medline Spinal Anesthesia 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 200,702 kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP due to quality issues with the drug 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 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 kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. The recall is classified as Class I and remains ongoing.

Which Products Are Affected

The affected products are Medline kits with the following SKUs containing the recalled drug: DYNJRA0102A, DYNJRA0143B, DYNJRA0205B, DYNJRA0255B, DYNJRA0320, DYNJRA0320A, DYNJRA0413C, DYNJRA0461D, DYNJRA0945, DYNJRA1140B, DYNJRA1192, DYNJRA1240, DYNJRA1288, DYNJRA1301, DYNJRA1304, DYNJRA1376, DYNJRA1477A, DYNJRA1538, DYNJRA1558A, DYNJRA1560A, DYNJRA1565, DYNJRA1577C, DYNJRA1584, DYNJRA1740A, DYNJRA1744A, DYNJRA1750A, DYNJRA1784, DYNJRA1790, DYNJRA1796, DYNJRA1802B, DYNJRA1818, DYNJRA1839, DYNJRA1884, DYNJRA1884A, DYNJRA1889, DYNJRA1929, DYNJRA1969, DYNJRA1982, DYNJRA1983A, DYNJRA1987, DYNJRA2005, DYNJRA2023, DYNJRA2068A, DYNJRA2088, DYNJRA2115, DYNJRA2117, DYNJRA2140, DYNJRA2153, DYNJRA2213, DYNJRA2225, DYNJRA2349, DYNJRA2360, DYNJRA2371, DYNJRA2381, DYNJRA2432A, DYNJRA2532, DYNJRA2534, DYNJRA2556, DYNJRA2566A, DYNJRA2575, DYNJRA2592, DYNJRA2597, DYNJRA2605, DYNJRA2606, DYNJRA2607, DYNJRA2607A, DYNJRA2611, DYNJRA2613, DYNJRA2618A, DYNJRA2634, DYNJRA2638, DYNJRA2639, DYNJRA2641, DYNJRA2653, DYNJRA2669, DYNJRA2670, DYNJRA2672 and additional listed SKUs. Specific lot numbers and UDI/DI codes for each SKU are detailed in the recall notice. A total of 200,702 kits are affected with distribution in the US nationwide, US Virgin Islands, and countries including Bahamas, Panama, and Barbados. Recall number Z-2237-2026.

What You Should Do

The recall was initiated voluntarily by the firm with notifications via email, fax, letter, press release, telephone, and visit. Consumers and facilities should refer to the recalling firm for return or other instructions.

Why This Matters

This Class I recall involves spinal anesthesia kits distributed worldwide, posing potential risks due to the quality issues with the included anesthetic drug.

Source

FDA Recall Z-2237-2026 - 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, LP is recalling 200,702 kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP due to quality issues with the drug 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.