FDAFDA recall Z-2770-2026 · Jul 29, 2026
Penumbra, Inc.: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall
Recall found
Product
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Reason for recall
Due to manufacturing issues, reperfusion catheters may fractures
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Quantity
- N/A
- 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.
- Recalling firm
- Penumbra, Inc., Livermore, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-03
Source: openFDA enforcement record Z-2770-2026 · search recall number Z-2770-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.