Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Recalling company
- Penumbra, Inc.
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Reason
- Due to manufacturing issues, reperfusion catheters may fractures
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 3, 2026
- Reported
- Jul 29, 2026
- Distribution
- Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Company location
- Livermore, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2770-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2770-2026 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.