BD Regional Block Needles Recalled for Missing Contraindications in Instructions
Becton Dickinson is recalling BD Regional Block Needles because the instructions for use lack general contraindications, as advised by the European Notified Body.
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, but the source text identifies the issue as a documentation error (missing contraindications in the IFU) without reporting any injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Becton Dickinson & Company is recalling BD Regional Block Needles 22G x 1.50in (Catalog No. 408348). The recall involves 105,880 units distributed across 18 U.S. states and four foreign countries: Australia, Canada, Belgium, and Singapore.
The recall was initiated after the European Notified Body, NSAI, advised that the instructions for use (IFU) need to be updated to include general contraindications. The agency has classified this as a Class II recall. All lots within the expiration date are affected, identified by UDI (01)50382904083484.
Healthcare providers and facilities should stop using the affected needles and contact Becton Dickinson for further instructions. Consumers should not use these products and should return them to the point of purchase or contact the manufacturer.
The recalled product
- Product
- BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 105,880
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)
- All lots within expiration date UDI: (01)50382904083484
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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