FDAFDA recall Z-3180-2026 · Sep 23, 2026
embecta Medical II LLC: EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Sam recall
Recall found
Product
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- No UDI/All products labeled "for Investigational Use Only"
- Quantity
- 3000 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.
- Recalling firm
- embecta Medical II LLC, Parsippany, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2023-07-26
Source: openFDA enforcement record Z-3180-2026 · search recall number Z-3180-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.