Medline Spinal Anesthesia Kits Recall
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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 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, medical-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 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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