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Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Recalled July 29, 2026 · FDA recall Z-2770-2026 · Penumbra
Hazard
Due to manufacturing issues, reperfusion catheters may fractures · FDA Class II
Units
N/A
Sold at
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.
Description
Due to manufacturing issues, reperfusion catheters may fractures
Product
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Manufacturer(s)
Penumbra, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →