FDA Device recall Z-3179-2026
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100 by Embecta Medical Ii, citing retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3179-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-26 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Embecta Medical Ii |
| Distribution | US |
Product
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Reason
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Identifiers
| code_info | No UDI/All products labeled "for Investigational Use Only" |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Embecta Medical Ii
- EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
FDA Device · Class II · 2026-09-23 · Embecta Medical Ii
All Embecta Medical Ii recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3179-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.