RED 68 recallZ-2770-2026 · Penumbra, Inc. · initiated Jun 3, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Penumbra, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing issues, reperfusion catheters may fractures
FDA root cause category: Under Investigation by firm
What the company is doing
On June 2, 2026, Penumbra issued a Urgent Medical Device Recall Notification to affecte consignees via FedEx. Penumbra asked consignees to take the following actions: 1. Review inventory and remove affected units from inventory and place in quarantine for return. 2.Complete and return the response form to [email protected]. Your Penumbra representative will work with you directly to arrange return and credit of affected devices. If you do not have any affected product, please still complete the response form and return. 3. Share recall notification with all users of the product within your facility.
Recall details
- Recall number
- Z-2770-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 3, 2026
- Posted by the FDA
- Jul 21, 2026
- Recalling firm
- Penumbra, Inc.
- Product code
- NRY
- FDA submissions
- K211411
- 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.
Product description
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Code information (models, lots, serial numbers)
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RED 68 RED68KIT-RPenumbra, Inc. · Catheter, Thrombus Retriever1 recall31 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K211411 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- RED 68 RED68-SPenumbra, Inc. · Catheter, Thrombus Retriever2 reports
- RED 68 RED68KIT-APenumbra, Inc. · Catheter, Thrombus Retriever1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page