FDA DevicesClass I
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL,...
Published: June 10, 2026Recall ID: Z-2251-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.
Additional Source Details
| Field | Value |
|---|---|
| City | Franklin Lakes |
| State | NJ |
| Event id | 98842 |
| Address 1 | 1 Becton Dr |
| Code info | Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01). |
| Postal code | 07417-1815 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 330 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260529 |
Overview
- Recalling FirmBecton Dickinson & Company
- StatusOngoing
- Risk LevelClass I
- DistributionNationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.