Medline Spinal Trays Recall Due to Bupivacaine Quality Issues
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Medline Industries, LP is recalling 41,720 spinal procedure 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 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 initiated a voluntary recall of kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP. The recall was triggered after the drug component was recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. This is a Class I recall.
Which Products Are Affected
The recall covers 41,720 kits distributed worldwide, including US nationwide distribution, the US Territory of Virgin Islands, and the countries of Bahamas, Panama, and Barbados. Affected Medline kit SKUs include:
- SPINAL TRAY W/PENCIL POINT NDL (DYNJRA0245)
- SPINAL TRAY W/PENCIL POINT NDL (DYNJRA0555)
- SPINAL TRAY (DYNJRA0836A)
- SPINAL TRAY (DYNJRA0978A)
- TRAY, SPINAL, WHIT 24GX4 (DYNJRA1034)
- SPINAL BLOCK 25G WHTCRE 5S BU (DYNJRA9028)
- TRAY, SPINAL PENCIL POINT 25G (DYNJRA9030)
Multiple lot numbers and UDI/DI codes are affected for each SKU. The recalling firm is Medline Industries, LP, 3 Lakes Dr, Northfield, IL 60093-2753. Recall number Z-2233-2026. Recall initiation date: April 10, 2026.
What You Should Do
Consumers and healthcare facilities should check inventory for the affected kits and follow instructions provided by Medline Industries for returns or further guidance. Contact information for returns or refunds will be provided by the firm.
Why This Matters
The recalled kits contain an anesthetic component with potential quality and efficacy issues, posing a risk to patients undergoing spinal procedures.
Source
FDA recall Z-2233-2026
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 (1,554 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.