Penumbra System (RED 62 Reperfusion Catheter) Penumbra System Recall
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Penumbra System (RED 62 Catheter) Penumbra System recalled?
Due to manufacturing issues reperfusion catheters may fracture.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Agency record number
- Z-3331-2026
- Product
- Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number…
- Recalling firm
- Penumbra Inc.
- Quantity
- 43
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- Recall started
- July 24, 2026
- Report date
- October 7, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)