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 3,000 pen needles labeled 'For Investigational Use Only' as if they were approved commercial devices. These samples were intended only for research and testing, not for patient use. The needles were distributed across 22 U.S. states.
- Check if you have pen needles with the catalog number 320122 labeled 'For Investigational Use Only'.
- Do not use these needles for patient care or self-injection.
- Contact Embecta Medical II LLC or your supplier to return affected units.
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
3000 Final Count (in EA)
Manufactured in
300 Kimball Dr Ste 300, N/A, Parsippany, NJ, United States
Products
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3180-2026More Embecta recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.