FDA Device recall Z-2249-2026
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in
- FDA Device
- Class I
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class I recall of BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in by Becton Dickinson And, citing 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 identif….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2249-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-27 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD¿Spinal Tray with BD¿Quincke 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: 405621, 405735.
Reason
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.
Identifiers
| code_info | 1. Catalog Number: 405621. UDI Numbers: (01)00382904056216(17)260601(10)B01V142D, (01)00382904056216(17)260628(10)B01V1…1. Catalog Number: 405621. UDI Numbers: (01)00382904056216(17)260601(10)B01V142D, (01)00382904056216(17)260628(10)B01V176D. Lot Numbers (Expiration Date): B01V142D (2026-06-01), B01V176D (2026-06-28). 2. Catalog Number: 405735. UDI Numbers: (01)00382904057350(17)260601(10)B01V149D, (01)00382904057350(17)261001(10)B01V190D. Lot Numbers (Expiration Date): B01V149D (2026-06-01), B01V190D (2026-10-01). |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2249-2026%22
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