BD Stimex Insulated Needle Recall for Missing Contraindications
Becton Dickinson is recalling BD Stimex Insulated Needles because the instructions for use lack general contraindications.
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 driven by a labeling omission (missing contraindications) rather than a physical defect or reported injury, fitting the rubric for minor labeling errors.
Plain-English summary
Becton Dickinson & Company is recalling BD Stimex Insulated Needles (22G x 2.13in, Catalog No. 404204) because the instructions for use (IFU) require an update to include general contraindications. The recall was initiated after the European Notified Body, NSAI, advised BD that the IFU needed this specific information.
The affected products are distributed in the United States and in Australia, Canada, Belgium, and Singapore. The recall covers all lots within the expiration date, identified by UDI (01)50382904042047. The agency has classified this as a Class II recall.
The recalled product
- Product
- BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 16,250
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)50382904042047
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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