FDAFDA · Food and drugs·Recall number Z-2770-2026
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Published July 29, 2026 · Recall initiated: June 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to manufacturing issues, reperfusion catheters may fractures
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Penumbra, Inc.
- Distributor
- 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.
- Lot
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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