BD Ultra-Fine Pen Needles Recalled for Incorrect US Labeling
Becton Dickinson is recalling 2.8 million BD Ultra-Fine Pen Needles because US cartons are missing specific compatibility information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where specific compatibility information is missing, fitting the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Becton Dickinson & Company is recalling 2,881,200 units of BD Ultra-Fine Pen Needles 32G x 4mm (Catalog Number 320122). The affected units are identified by Batch Number 9352052 and an expiration date of 20241231. The recall was initiated because the product shelf cartons were incorrectly labeled as products intended for the Latin American market.
Although the product description on the label is correct, the labels are missing information pertinent to users in the US regarding compatibility with specific pen needles. The recall is classified as Class II by the FDA.
Consumers who have these specific needles should stop using them and contact Becton Dickinson & Company for instructions on how to return the product.
The recalled product
- 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
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 2,881,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Number: 9352052 Exp. Date: 20241231
Distribution
Distributed nationwide across the United States.
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