Class II — Becton Dickinson & Company
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing. |
| Product | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122 |
| Quantity | 2,881,200 units |
| Distribution | Nationwide |
| Initiated | 2020-10-23 |
| Classified | 2020-11-27 |
| Terminated | 2023-09-08 |
| Recall number | Z-0508-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Company (Z-0508-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86679/
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