BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3 — Class I medical device recall Z-2255-2026
Ongoing recall by Becton Dickinson & Company, reported 2026-06-10, distributed nationwide. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in
| Recall number | Z-2255-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2026-04-27 |
| Classified | 2026-05-29 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 13,320 units |
| UPC / GTIN / UDI-DI | 00382904056728, 00382904056735, 00382904056742, 00382904056759, 00382904057091, 00382904057213, 00382904057237, 00382904067045, 10885403469497 |
| Lot numbers | B01V174D, B01V183D, B01V189D, B01V198D, B01V218D, B01V225D, B01V232D, B01V281D, B02V174D, B02V202D, B02V211D, B02V217D, B02V227D, B02V246D, B02V254D, B03V267D |
| Model numbers | 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704 |
Product
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.
Reason for recall
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
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-2255-2026. 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.