Recall Ledger

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection recall (Medline Industries, LP)

Medical deviceClass IOngoing

Summary: Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026. Reason: 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.

What is being recalled

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

Why

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.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

How to tell if yours is affected

Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2235-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedApril 10, 2026
ReportedJune 3, 2026
CompanyMedline Industries, LP
Company locationNorthfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity4370 kits

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Official FDA record