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FDA · Medical devices ·

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall

Penumbra, Inc. recalled Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT on July 29, 2026 because of due to manufacturing issues, reperfusion catheters may fractures. It was sold nationwide.

Why it was recalled

Due to manufacturing issues, reperfusion catheters may fractures

What's recalled

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Quantity: N/A

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Penumbra, Inc., Livermore, CA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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, I…
Status
Ongoing
Recall number
Z-2770-2026
Source
U.S. Food and Drug Administration

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