FDA Medical devices recall ·
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2253-2026
- Date
- (initiated April 27, 2026)
- Company / brand
- Becton Dickinson & Co.
1 Becton Dr, Franklin Lakes, NJ, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 290 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke 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: 405741.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 405741. UDI Number: (01)00382904057411(17)261001(10)B02V204D. Lot Number (Expiration Date): B02V204D (2026-10-01).
Distribution
Nationwide 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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi North Carolina Nebraska New Hampshire New Jersey Nevada New York Ohio Oregon Pennsylvania Puerto Rico South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2253-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.