Class IIDeviceOngoing

embecta Medical II LLC

EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100

Reason for recall

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Details

Recall number: Z-3179-2026
Event ID: 99593
Recall initiated: Jul 26, 2023
Classified: Sep 16, 2026
Reported: Sep 23, 2026
Quantity: 4300 Final Count (in EA)
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.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Parsippany, NJ, United States
Lot / code info: No UDI/All products labeled "for Investigational Use Only"