Penumbra System RED 68 Reperfusion Catheter recall
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Why was Penumbra System RED 68 Reperfusion Catheter recalled?
Due to manufacturing issues, reperfusion catheters may fractures
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Recalling firm
- Penumbra, Inc.
- 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.
- Recall date
- July 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)