FDA recall, , Moderate risk
Embecta Nano Pro Un-Cannulated Demo Samples
Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Summary by Recall Canary from the FDA notice
What happened
embecta Medical II LLC of Parsippany, New Jersey, recalled pen needles labeled 'For Investigational Use Only' that were inadvertently distributed as commercially marketed devices. The recall began on July 26, 2023, and was added to the FDA's Enforcement Report on September 16, 2026, affecting products EWO_02513 and EWO_02512.
Distribution was nationwide across 22 states, including Alabama, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
- Lot code
- No UDI/All products labeled "for Investigational Use Only"
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
- Lot code
- No UDI/All products labeled "for Investigational Use Only"
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Massachusetts, Kentucky, Connecticut, Texas, New Jersey, Ohio, Minnesota, Louisiana, Indiana, New Hampshire, Alabama, California, New York, Florida, North Carolina, Michigan, South Carolina, Arizona, Virginia, Georgia, Pennsylvania, Missouri.
- Company
- embecta Medical II LLCParsippany, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99593
- Recall numbers
- Z-3179-2026 to Z-3180-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
