# Class II recall Z-3331-2026: Penumbra Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3331-2026 |
| Recalling firm | Penumbra Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Brand Name: Penumbra System (RED 62 Reperfusion Catheter)  Product Name: Penumbra System (RED 62 Reperfusion Catheter)  Model/Catalog Number: THNDRRED62SKIT  Software Version: N/A  Product Description: Product common name: Percutaneous catheter    A complete product description is provided in Attachment 1 (HHE-2026-002 RED62).  Component: Penumbra System |
| Reason | Due to manufacturing issues reperfusion catheters may fracture. |
| Quantity | 43 |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI. |
| Recall initiated | 2026-07-24 |
| Reported | 2026-10-07 |
| Firm location | Alameda, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3331-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.