BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 340,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level 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 medical device where the failure to meet Sterility Assurance Level standards poses a risk of harm (infection) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling 340,000 units of BD 3ml Syringe Luer-Lok Tip with BD PrecisionGlide Needle 18G x 1 1/2 (Catalog #309580). The affected lots are identified by codes 6090832 (expiration 2021-03) and 6176715 (expiration 2021-06). The product was 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. This single-use hypodermic syringe is intended for use by health care professionals for general purpose fluid aspiration and injection.
Health care professionals should stop using the affected syringes and contact Becton Dickinson for further instructions. Consumers should not use these medical devices.
The recalled product
- Product
- BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 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
- 340,000
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)
- 6090832 2021-03 6176715 2021-06
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Company
See all →- SevereBD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
- SevereBD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
- SevereBD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighBD 10 mL Syringes Recalled Due to Improperly Seated Stopper
FDA (Devices) · 2015-02-11
- HighBD 10 ml Syringes Recalled for Potential Open Seals and Sterility Compromise
FDA (Devices) · 2021-02-24
- HighBecton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities
FDA (Devices) · 2016-06-15
- HighBecton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues
FDA (Devices) · 2016-06-15
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18
- HighBD Insulin Syringes Recalled for Sterility Defect
FDA (Devices) · 2023-03-22