Key facts
| Recalling firm | Becton Dickinson & Company |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | 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. |
| Classification | Class I |
| Recall number | Z-2248-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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 this classification means
FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Becton Dickinson & Company and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: 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 recall is tracked under FDA recall number Z-2248-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What consumers should do
Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- 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. -- and the recall number Z-2248-2026. If it matches, stop using or distributing it and contact Becton Dickinson & Company or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Becton Dickinson & Company’s FDA history
Argus HQ has recorded 13 total FDA actions tied to Becton Dickinson & Company: 0 warning letters, 13 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.
- What should someone who has this product do?
- Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (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.) and recall number Z-2248-2026, then follow Becton Dickinson & Company's recall instructions.
- Has Becton Dickinson & Company had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 13 total FDA actions tied to Becton Dickinson & Company, including 13 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2248-2026.
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Related enforcement actions
Full FDA history for Becton Dickinson & CompanyCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Recall Record: Class I Recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x… by Becton Dickinson & Company. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-becton-dickinson-and-company-z-2248-2026
"Recall Record: Class I Recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x… by Becton Dickinson & Company." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-becton-dickinson-and-company-z-2248-2026.
Argus HQ Research. "Recall Record: Class I Recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x… by Becton Dickinson & Company." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-becton-dickinson-and-company-z-2248-2026.
@misc{argushq_argushq_ai_recall_fda_recall_becton_dickinson_and_company_z_2248_2026_2026,
title = {Recall Record: Class I Recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x… by Becton Dickinson & Company},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-becton-dickinson-and-company-z-2248-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗