Medline Kits Recall Involving Bupivacaine HCL Due to 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 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 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 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 ↗
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 (1,135 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.