Device recall
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
- Recall number
- Z-3180-2026
- Event id
- 99593
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- embecta Medical II LLC
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 26, 2023
- Center classification date
- Sep 16, 2026
- Product code
- FMI
- Device type
- Needle, Hypodermic, Single Lumen
- Reason
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- Root cause
- Nonconforming Material/Component
- Quantity
- 3000 Final Count (in EA)
- Code info
- No UDI/All products labeled "for Investigational Use Only"
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K213478
- Location
- Parsippany, NJ, United States