Data Foundry

Medical device recalls 2026

Medline kits containing Huons Co — Class I medical device recall Z-2234-2026

Ongoing recall by Medline Industries, LP, reported 2026-06-03, distributed nationwide. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was

Recall numberZ-2234-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-04-10
Classified2026-05-28
Reported by FDA2026-06-03
DistributedNationwide (US)
Countries outside the USBB, BS, PA
Quantity270 kits
Reason classesmicrobial contamination
UPC / GTIN / UDI-DI10193489457605, 10195327008413, 40193489457606, 40195327008414
Lot numbers24DMB099, 25CMB575, 25DMF105

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.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2234-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.