FDAFDA recall Z-3331-2026 · Oct 7, 2026
Penumbra Inc.: Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (R recall
Recall found
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 for recall
Due to manufacturing issues reperfusion catheters may fracture.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Quantity
- 43
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- Recalling firm
- Penumbra Inc., Alameda, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-24
Source: openFDA enforcement record Z-3331-2026 · search recall number Z-3331-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.