FDA Medical devices recall ·
Penumbra System RED 68 Reperfusion Catheter recall
- Recall number
- Z-2770-2026
- Date
- (initiated June 3, 2026)
- Company / brand
- Penumbra, Inc.
6262 Patterson Pass Rd Ste A, Livermore, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Why was it recalled?
Due to manufacturing issues, reperfusion catheters may fractures
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
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.
States: Alaska Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kentucky Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2770-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.