FDA-Device2026-09-23Class IIMISBRANDING
Embecta Medical II investigational pen needles inadvertently distributed as commercial devices
What this means
Embecta Medical II LLC inadvertently distributed 4,300 pen needles labeled 'For Investigational Use Only' as regular commercial products across 22 US states. These devices were meant only for research and testing, not for patient use. No injuries have been reported.
- Check if you have Embecta EWO_02512 Nano Pro Un-Cannulated pen needles (catalog number 320550)
- If you do, do not use them and contact your healthcare provider or the distributor
- Embecta will provide instructions for return or disposal
The agency's original wording
Hazard
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
4300 Final Count (in EA)
Manufactured in
300 Kimball Dr Ste 300, N/A, Parsippany, NJ, United States
Products
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3179-2026More Embecta recalls
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