FDA Medical devices recall ·
EWO_02513 ( recall
- Recall number
- Z-3180-2026
- Date
- (initiated July 26, 2023)
- Company / brand
- embecta Medical II LLC
300 Kimball Dr Ste 300, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3000 Final Count (in EA)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Why was it recalled?
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
No UDI/All products labeled "for Investigational Use Only"
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.
States: 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 Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3180-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.