Recall Z-3180-2026 ยท FMI Needle, Hypodermic, Single Lumen
embecta Medical II LLC
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
| Date | Sep 16, 2026 (initiated Jul 26, 2023) |
| Status | Open, Classified |
| Reason | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| Root cause | Nonconforming Material/Component |
| Action | On July 26, 2023, Embecta Medical II LLC ( subsidiary of Becton, Dickinson and Company 'BD's) issued a recall notification to consignees via email. Embecta ask consignees to take the following actions: 1. Immediately review your inventory for the specific Catalog (Ref) numbers listed above. If it is labeled with a "For investigational Use Only" statement, discard the product. 2. Share this advisory notification with anyone in your facility/office who may have received the product to ensure they are also aware of this advisory. 3. Identify all patients that may have received the affected |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213478 | BD Pen Needle Becton, Dickinson and Company, Jun 28, 2022 |