Becton Dickinson Recalls 3mL Safety-Lok Syringes Due to Incorrect Scale Markings
Becton Dickinson is recalling 428,800 3mL Safety-Lok Syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.
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 classified as FDA Class II. The defect involves incorrect scale markings which could lead to dosing errors, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving potential harm without confirmed adverse events.
Plain-English summary
Becton Dickinson & Company is recalling 428,800 units of 3mL Safety-Lok Syringes, Catalog Number 309606, UDI 30382903096061. The recall affects Lot Number 8307694. The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI, as well as to Suriname.
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. This defect may make it difficult to accurately measure the volume of medication or fluid being administered.
Healthcare providers and facilities should stop using the affected syringes and contact Becton Dickinson for further instructions. Consumers who have purchased these syringes should stop using them and contact the manufacturer or their healthcare provider.
The recalled product
- Product
- 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 428,800
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)
- Lot Number 8307694
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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