Z-2770-2026 Class II Ongoing
FDA device recall Z-2770-2026 was initiated by Penumbra, Inc. on June 3, 2026 and is designated Class II. Reason for recall: Due to manufacturing issues, reperfusion catheters may fractures The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Reason for Recall
Due to manufacturing issues, reperfusion catheters may fractures
Distribution Pattern
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.
Code Information
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038