FDAFDA · Food and drugs·Recall number Z-3179-2026
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Published September 23, 2026 · Recall initiated: July 26, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- embecta Medical II LLC
- Distributor
- 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.
- Lot
- No UDI/All products labeled "for Investigational Use Only"
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.