EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo: recall status
Notice names this product. embecta Medical II’s EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo is named in FDA Class II recall Z-3179-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. Identifying details: No UDI/All products labeled "for Investigational Use Only". Units affected: 4300 Final Count (in EA). Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo
Company / brand
embecta Medical II
Lot / serial / date codes
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.
Agency product description and boundaries
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.