Medline kits containing Huons Co — Class I medical device recall Z-2231-2026
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-2231-2026 |
|---|---|
| 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 | 1,100 kits |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 10195327179830, 10195327365400 |
| Lot numbers | 24FBT395, 24FBT396, 25CBG043, 25FBA408, 25HBE663, 26ABS307, 26CBA272 |
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.
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-2231-2026. 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.