embecta Medical II LLC recalls EWO_02512
- Recalling company
- embecta Medical II LLC
- Product
- EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
- Reason
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 26, 2023
- Reported
- Sep 23, 2026
- 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.
- Status
- Ongoing
- Quantity
- 4300 Final Count (in EA)
- Lot / codes
- No UDI/All products labeled "for Investigational Use Only"
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3179-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3179-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.