BD 10 ml Syringes Recalled for Potential Open Seals and Sterility Compromise
Becton Dickinson is recalling 155,200 10 ml syringes because open packaging seals may compromise sterility. The product was distributed in the US and Canada.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a packaging defect potentially compromises sterility, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling 155,200 units of BD Hypodermic Syringe 10 ml, eccentric tip (Catalog Ref No. 305482). The recall is due to a defect where the product packaging may exhibit open seals.
An open seal impacts package integrity and potentially compromises the sterility of the syringe. The affected product has a UDI of 00382903054824, Lot # 8142303, and an expiration date of 31-May-2023.
The product was distributed nationwide in the United States and in Canada. The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop use or return the product.
The recalled product
- Product
- BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 155,200
Distribution
Distributed nationwide across the United States.
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