TemporaryFDAOngoing
Can cause harm that is usually temporary.
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Check the device or its packaging for
No UDI/All products labeled "for Investigational Use Only"
- Why
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- Distributed
- US Nationwide distribution 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, MO.
- Company
- embecta Medical II LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3180-2026 · retrieved 16 September 2026
Read the official notice