Penumbra Inc. recalls Brand Name: Penumbra System
- Recalling company
- Penumbra Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 24, 2026
- Reported
- Oct 7, 2026
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- Status
- Ongoing
- Quantity
- 43
- Lot / codes
- Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Company location
- Alameda, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3331-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3331-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.