BD Ultra-Fine Pen Needles 32G x 4mm — Class II medical device recall Z-0508-2021
Terminated recall by Becton Dickinson & Company, reported 2020-12-09, distributed nationwide. Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the pro
| Recall number | Z-0508-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-11-27 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2023-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,881,200 units |
| Reason classes | labeling |
| Lot numbers | 20241231, 9352052 |
| Model numbers | 320122 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0508-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.