BD 5ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 22,400 units of 5ml 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 (medical device) where the sterilization process was not fully met, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Becton Dickinson & Company is recalling 22,400 units of BD 5ml Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm), Catalog #305062. The affected products 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. This deviation from the sterilization process may affect the sterility of the medical devices.
Healthcare providers and facilities should check their inventory for the specific catalog number and code information (6204878 2021-07) to identify affected units. Users should stop using the recalled syringes and contact Becton Dickinson for instructions on return or replacement.
The recalled product
- Product
- BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 22,400
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)
- 6204878 2021-07
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 · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighBD 10 mL Syringes Recalled Due to Improperly Seated Stopper
FDA (Devices) · 2015-02-11
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18
- 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 Issues
FDA (Devices) · 2016-06-15
- HighBecton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities
FDA (Devices) · 2016-06-15
- ModerateBD Recalls Oral Dispensing Syringes Due to Mixed Tip Complaints
FDA (Devices) · 2012-12-26