Medline kits containing Huons Co — Class I medical device recall Z-2233-2026
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 number | Z-2233-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-04-10 |
| Classified | 2026-05-28 |
| Reported by FDA | 2026-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BS, PA |
| Quantity | 41,720 kits |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 10884389285701, 10884389573488, 10888277270923, 10889942760695, 10889942785728, 10889942826827, 10889942833795, 40884389285702, 40884389573489, 40888277270924, 40889942760696, 40889942785729, 40889942826828, 40889942833796 |
| Lot numbers | 23GBC535, 23GBD403, 23GBM182, 23HBA325, 23HBG512, 23HBS638, 23HBS639, 23IBG784, 23IBG977, 23IBH382, 23JDB931, 23JDC308, 24BBP041, 24BBP046, 24BBQ043, 24BDA117, 24BME560, 24CDA047, 24DBA515, 24EDB670, 24EDB889, 24FBJ026, 24FBJ511, 24GBD227, 24GMB114, 24GMI471, 24HMA551, 24HMB241, 24HMB245, 24HMD548, 24IMG162, 24JMA156, 24KDB290, 25ABP041, 25BBC565, 25DBE493, 25DBE494, 25DBE495, 25DMJ266, 25EBD163 and 41 more |
Product
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
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-2233-2026. 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.