Becton Dickinson & Company medical device recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98842
- Recall initiated
- Apr 27, 2026
- Classified by FDA
- May 29, 2026
- Posted in Enforcement Report
- Jun 10, 2026
- Recalling firm
- Becton Dickinson & Company
- Firm location
- Franklin Lakes, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 10
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 27, 2026. FDA classified it 32 days later, on May 29, 2026. This recall event covers 10 separate products, each with its own FDA recall number. Distribution reported by FDA: 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. Becton Dickinson & Company has 162 recalls in our records.
Recalled products (10)
Z-2248-2026 Class I Ongoing
BD¿Spinal Tray with 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: 405609.
Codes / lots: Catalog Number: 405609. UDI Numbers: (10)00382904056094(17)261001(10)B01V212D, (10)00382904056094(17)270101(10)B01V238D. Lot Numbers (Expiration Date): B01V212D (2026-10-01), B01V238D (2027-01-01).
Quantity: 990 units
Z-2249-2026 Class I Ongoing
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.
Codes / lots: 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).
Quantity: 3,130 units
Z-2250-2026 Class I Ongoing
BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.
Codes / lots: Catalog Number: 405632. UDI Number: (01)00382904056322(17)270101(10)B01V231D; Lot Number (Expiration Date): B01V231D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056322(17)270101(10)B02V248D; Lot Number (Expiration Date): B02V248D (2027-01-01).
Quantity: 890 units
Z-2251-2026 Class I Ongoing
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.
Codes / lots: Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01).
Quantity: 330 units
Z-2252-2026 Class I Ongoing
BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.
Codes / lots: 1. Catalog Numbers: 400868. UDI Numbers: (01)10885403469510(17)261001(10)B01V206D, (01)10885403469510(17)261001(10)B01V220D, (01)10885403469510(17)270101(10)B02V266D. Lot Number (Expiration Date): B01V206D (2026-10-01), B01V220D (2026-10-01), B02V266D (2027-01-01). 2. Catalog Number: 405652. UDI Numbers: (01)00382904056520(17)270130(10)B01V353D, (01)00382904056520(17)270101(10)B02V267D. Lot Numbers (Expiration Date): B01V353D (2027-01-30), B02V267D (2027-01-01).
Quantity: 3,550 units
Z-2253-2026 Class I Ongoing
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.
Codes / lots: Catalog Number: 405741. UDI Number: (01)00382904057411(17)261001(10)B02V204D. Lot Number (Expiration Date): B02V204D (2026-10-01).
Quantity: 290 units
Z-2254-2026 Class I Ongoing
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.
Codes / lots: Catalog Number: 405658. UDI Number: (01)00382904056582(17)261001(10)B01V217D. Lot Number (Expiration Date): B01V217D (2026-10-01).
Quantity: 150 units
Z-2255-2026 Class I Ongoing
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.
Codes / lots: 1. Catalog Number: 400866. UDI Number: (01)10885403469497(17)270101(10)B01V232D. Lot Number (Expiration Date): B01V232D (2027-01-01). 2. Catalog Number: 405672. UDI Number: (01)00382904056728(17)270101(10)B03V267D. Lot Number (Expiration Date): B03V267D (2027-01-01). 3. Catalog Number: 405673. UDI Numbers: (01)00382904056735(17)261001(10)B01V225D, (01)00382904056735(17)270101(10)B01V281D, (01)00382904056735(17)261001(10)B02V211D, (01)00382904056735(17)261001(10)B02V217D. Lot Numbers (Expiration Date): B01V225D (2026-10-01), B01V281D (2027-01-01), B02V211D (2026-10-01), B02V217D (2026-10-01). 4. Catalog Number: 405674. UDI Number: (01)00382904056742(17)261001(10)B01V218D. Lot Number (Expiration Date): B01V218D (2026-10-01). 5. Catalog Number: 405675. UDI Numbers: (01)00382904056759(17)261001(10)B01V183D, (01)00382904056759(17)260901(10)B01V198D. Lot Numbers (Expiration Date): B01V183D…
Quantity: 13,320 units
Z-2256-2026 Class I Ongoing
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 Number: 405671.
Codes / lots: Catalog Number: 405671. UDI Number: (01)00382904056711(17)270101(10)B01V275D. Lot Number (Expiration Date): B01V275D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056711(17)270101(10)B01V294D; Lot Number (Expiration Date): B01V294D (2027-01-01).
Quantity: 0 units
Z-2257-2026 Class I Ongoing
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: 405637, 405707.
Codes / lots: 1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D, (01)00382904056377(17)270101(10)B01V241D, (01)00382904056377(17)270101(10)B01V265D, (01)00382904056377(17)261001(10)B02V183D. Lot Numbers (Expiration Date): B01V160D (2026-06-28), B01V241D (2027-01-01), B01V265D (2027-01-01), B02V183D (2026-10-01). 2. Catalog Number: 405707. UDI Number: (01)00382904057077(17)270101(10)B02V230D. Lot Number (Expiration Date): B02V230D (2027-01-01).
Quantity: 5,940 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98842
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.