BD Insulin Syringes Recalled for Incorrect Needle Length Labeling
Becton Dickinson is recalling specific lots of BD Insulin Syringes because some polybags were mislabeled with the wrong needle length and gauge.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding needle specifications, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Becton Dickinson & Company is recalling 7,839,340 units of BD Insulin Syringes with the BD Ultra-Fine needle, 1 mL, 12.7mm, 30G (Catalog/REF 328466). The recall affects Lot Numbers 6291768, 6312558, and 6340590. The products were distributed nationwide, including in California, Connecticut, Florida, Illinois, Louisiana, Maine, Michigan, North Carolina, North Dakota, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, and Virginia.
The recall was initiated due to a product mislabeling issue. In Lot 6291768, some polybags were incorrectly labeled as BD Ultra-Fine needle 1 mL, 8mm, 31G (Catalog/REF 328468), while the shelf and case cartons were correctly labeled as 12.7mm, 30G. On August 25, 2017, the firm notified the FDA of a recall expansion to include Lot Numbers 6312558 and 6340590.
These syringes are intended for the subcutaneous injection of insulin. Consumers and healthcare providers should check the lot numbers on their syringes. If the lot number matches one of the recalled lots, they should stop using the product and contact Becton Dickinson or their supplier for instructions on return or replacement.
The recalled product
- Product
- BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 7,839,340
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)
- Lot Numbers: 6291768
Distribution
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