Use cautionMedical device recall · FDA · Published October 23, 2020
BD Ultra-Fine Pen Needles Recalled for Labeling Errors
Becton Dickinson recalls BD Ultra-Fine Pen Needles due to incorrect labeling. The cartons are labeled for the Latin American market, missing US compatibility info.
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.
Take action
Contact the company
📍Recalling firmBecton Dickinson & Company1 Becton Dr · Franklin Lakes, NJ 07417-1815
✎ GovInfoNow plain-language explainer
Becton Dickinson & Company is recalling BD Ultra-Fine Pen Needles (32G x 4mm) because the product shelf cartons were incorrectly labeled as products intended for the Latin American market. While the needle gauge and length description on the label is correct, the packaging lacks information pertinent to users in the US regarding compatibility with specific pen injectors. This recall affects 2,881,200 units distributed nationwide. Read more at govinfonow.com/recall/64063-bd-ultra-fine-pen-needles-32g-x-4mm-missing-us.
“BD Ultra-Fine Pen Needles Recalled for Labeling Errors.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/64063-bd-ultra-fine-pen-needles-32g-x-4mm-missing-us. Based on FDA recall #Z-0508-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0508-2021%22&limit=1).
The FDA announced on Oct. 23, 2020, that Becton Dickinson & Company is recalling BD Ultra-Fine Pen Needles because cartons were incorrectly labeled for the Latin American market, omitting U.S. compatibility information. The agency classified the Class II recall as voluntary.
How to tell if you have it
Brand: BD
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
Batch Number: 9352052
Exp. Date: 20241231
The hazard
Product shelf cartons were incorrectly labeled as products intended for the Latin American market, according to the FDA. Although the product description on the label is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
Context
GovInfoNow's records show Becton Dickinson & Company has 52 other recalls on record since 2017-05-31. Other recent recalls include a spinal tray recall due to quality issues from an FDA inspection (2026-04-27), a recall of 10mL Non-Sterile Luer-Lok Syringes for wrong syringe type (2026-01-27), and a Luer Tip Caps recall for failed biocompatibility testing (2025-10-14). Other recent recalls of similar products include B Braun Spinocan Spinal Needle Kits Recall: Potential Quality Issues, B Braun Medical Spinal Needle Kits Recall: Potential Quality Issues, and Braun Medical Spinal Needle Kits Recall: Potential Quality Issues with Bupivacaine (all 2026-05-06).
How to tell if you have this one
Check for BD Ultra-Fine Pen Needles 32G x 4mm (5/32'). Look for Catalog Number 320122 and Batch Number 9352052. The expiration date is 20241231. The product was distributed nationwide.
Brand
BD
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check your product details
Verify if you have BD Ultra-Fine Pen Needles with Catalog Number 320122 and Batch Number 9352052.
Contact the manufacturer
The record does not specify a remedy or return process, so you should contact Becton Dickinson & Company for further instructions on how to handle this recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0508-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0508-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.