BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 1,528,000 units of 3ml syringes because several lots did not receive the specified dose of irradiation required to meet sterility standards.
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 risk-of-harm product (sterile medical device) where the failure to meet sterility assurance levels presents a potential infection risk, but the source text does not report any illnesses or injuries, placing it at the maximum score of 3 per the rubric.
Plain-English summary
Becton Dickinson & Company is recalling 1,528,000 units of BD 3ml Syringe Luer-Lok Tip (Catalog #309604). These single-use hypodermic syringes are intended for use by health care professionals for general purpose fluid aspiration and injection. The affected lots were distributed nationwide.
The recall was initiated because BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. The specific lot codes and expiration dates affected include: 6061746 (2021-02), 6082982 (2021-02), 6089821 (2021-03), 6117858 (2021-04), 6117863 (2021-04), 6117889 (2021-04), 6117891 (2021-04), 6146962 (2021-04), 6173697 (2021-05), 6173767 (2021-06), 6173779 (2021-06), and 6208614 (2021-07).
Health care professionals should stop using the affected syringes and contact Becton Dickinson for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 1,528,000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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