Quick Facts at a Glance
- Recall Date
- June 3, 2026
- Hazard Level
- HIGH
- Brand
- Penumbra
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Penumbra
- Model numbers
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 3, 2026
Reported by FDA DEVICE
July 29, 2026
RecallRadar source check
August 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to manufacturing issues, reperfusion catheters may fractures
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Penumbra, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT. Reason: Due to manufacturing issues, reperfusion catheters may fractures. Classification: Class II. 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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