Embecta Medical Recalls Nano Pro Pen Needles Distributed as Commercial Devices
Embecta Medical II LLC is recalling Nano Pro Un-Cannulated Demo Samples because investigational-use-only pen needles 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 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 agency classifies this as a Class II recall involving a risk-of-harm product (medical device) where the hazard is the inadvertent distribution of investigational-use-only items as commercial devices, without reported injuries or illnesses in the source text.
Plain-English summary
Embecta Medical II LLC is voluntarily recalling 4,300 units of Nano Pro Un-Cannulated Demo Samples (Catalog number 320550). These products are labeled "For Investigational Use Only" but were retrospectively reported to have been inadvertently distributed as commercially marketed devices.
The recall covers products 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 classifies this as a Class II recall.
Consumers who possess these specific demo samples should stop using them and contact Embecta Medical II LLC for instructions on return or disposal. The products are intended for investigational use only and should not be used as commercially marketed devices.
The recalled product
- Product
- EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
- Manufacturer
- embecta Medical II LLC
- Category
- Medical Device — Pen Needles
- Affected units
- 4,300
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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