Embecta Medical Recalls Pen Needles Labeled for Investigational Use Only
Embecta Medical II LLC is recalling pen needles labeled 'For Investigational Use Only' that were inadvertently distributed as commercially marketed devices.
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 and involves a labeling/distribution error where investigational devices were distributed as commercial products. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Embecta Medical II LLC is recalling EWO_02513 (Catalog number 320122) Nano Un-Cannulated Demo Samples. The recall involves 3,000 units of pen needles that were labeled 'For Investigational Use Only' but were inadvertently distributed as commercially marketed devices.
The affected products were distributed nationwide in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, and MO. The agency has classified this as a Class II recall.
Consumers who have these specific pen needles should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
- Manufacturer
- embecta Medical II LLC
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 3,000
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)
- No UDI/All products labeled "for Investigational Use Only"
Distribution
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