Medline Kits Recall Involving Bupivacaine HCL Due to Quality Issues
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Medline Industries is recalling 270 kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to quality issues with the included drug product.
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 distributed kits containing Huons Co. 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.
Which Products Are Affected
The affected products are:
- BLOCK TRAY, Medline Kit SKU DYNJRA1181C; UDI/DI 10193489457605 (each), 40193489457606 (case); Lot Numbers 25DMF105 and 25CMB575
- SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA1860; UDI/DI 10195327008413 (each), 40195327008414 (case); Lot Number 24DMB099 A total of 270 kits are affected. Distribution was nationwide in the US, US Virgin Islands, and the countries of Bahamas, Panama, and Barbados.
What You Should Do
Consumers should stop using the affected kits. The recall was initiated voluntarily by the firm.
Why This Matters
This Class I recall involves devices distributed worldwide containing a drug component with potential quality and efficacy concerns.
Source
FDA Recall Z-2234-2026 - Medline Industries, LP
Original source: FDA Official Notice ↗
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