FDA recall Z-2770-2026

Product

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Reason for recall

Due to manufacturing issues, reperfusion catheters may fractures

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.

Key facts

Status

Ongoing

Initiation date

2026-06-03

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livermore, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2770-2026