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: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.. 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: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.

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 DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25DMF105; Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25CMB575; Medline Kit SKU DYNJRA1860: UDI/DI 10195327008413 each, 40195327008414 case, Lot Number 24DMB099.

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-2234-2026
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
Quantity270 kits

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