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Recall Observatory FDA recall evidence

Device product

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

Z-2231-2026

April 10, 2026

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 98837
Status
Ongoing
Classification
Class I
Quantity
1100 kits
Official record key
device-enforcement:Z-2231-2026

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 SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26CBA272; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26ABS307; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25HBE663; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25FBA408; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25CBG043; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 24FBT395; Medline SKU DYNJRA2151: UDI/DI 10195327365400 each, FI case, Lot Numbers: 24FBT396.

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.