Z-3180-2026 Class II Ongoing
FDA device recall Z-3180-2026 was initiated by embecta Medical II LLC on July 26, 2023 and is designated Class II. Reason for recall: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. The recall status is ongoing. Affected quantity: 3000 Final Count (in EA).
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 Final Count (in EA)
Product Description
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.
Distribution Pattern
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.
Code Information
No UDI/All products labeled "for Investigational Use Only"