Data Foundry

Medical device recalls 2026

Medline kits containing Huons Co — Class I medical device recall Z-2236-2026

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-2236-2026
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
Quantity30,120 kits
Reason classesmicrobial contamination
UPC / GTIN / UDI-DI10193489566123, 10198459155666, 10888277789838, 10889942802272, 10889942802289, 10889942873814, 10889942879236, 10889942935864, 40193489566124, 40198459155667, 40888277789839, 40889942802273, 40889942802280, 40889942873815, 40889942879237, 40889942935865
Lot numbers23GBR079, 23HBM569, 23HBR199, 23IBQ010, 23IBQ015, 23JBB581, 23JDC158, 23JDC468, 24BBR608, 24BDA655, 24DDB935, 24DLA279, 24EDB329, 24FBJ060, 24FBT398, 24FDA633, 24FDA638, 24FDA639, 24GBD224, 24JDB280, 24JDC049, 24KDB674, 24KDB682, 24LDA129, 24LDB606, 25ABP028, 25ADA237, 25ADB659, 25BBF629, 25BBH830, 25BBK828, 25DBF619, 25DBJ529, 25DMC357, 25DMG474, 25EBE523, 25EBS286, 25FBD584, 25FBD726, 25FBU644 and 31 more

Product

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline Kit SKU DYNJRA1212; 5) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1285; 6) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA9031; 7) SPINAL BLOCK TRAY 25G WHITACRE, Medline Kit SKU DYNJRA9032; 8) 25G SPINAL TRAY, Medline Kit SKU PAIN1239.

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-2236-2026. 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.