CLASS I ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &
Becton Dickinson is recalling BD¿Spinal Tray with BD¿Whitacre Needle, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2254-2026
- FDA event ID
- 98842
- Recalling firm
- Becton Dickinson, Franklin Lakes, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Apr 2026
- FDA classified
- 29 May 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Spinal Implants
Timeline
| 27 Apr 2026 | Recall initiated by company | |
| 29 May 2026 | Classified by FDA | +32 days |
| 10 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriMississippi
Questions about this recall
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.
Which lots are affected?
Catalog Number: 405658. UDI Number: (01)00382904056582(17)261001(10)B01V217D. Lot Number (Expiration Date): B01V217D (2026-10-01).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 98842This product is part of a recall event; the main page for the event is BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &.
More recalls from Becton Dickinson
All 364| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Quincke Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle, BD¿Quincke Needle recalled | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Quincke Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
Other Spinal Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |