Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2234-2026

April 10, 2026

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 98837
Status
Ongoing
Classification
Class I
Quantity
270 kits
Official record key
device-enforcement:Z-2234-2026

Official wording

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.

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.