Penumbra, Inc. 2026-07-29 Health serious FDA
Health · FDA · Recall #FDA-Z-2770-2026
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT Recall
Issued July 29, 2026 · Penumbra, Inc.
In July 2026, Penumbra, Inc. recalled the Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
Due to manufacturing issues, reperfusion catheters may fractures
What you should do
- 1 Stop using Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Penumbra, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Penumbra, Inc.
- Category
- Health
- Recall date
- July 29, 2026
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-2770-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Penumbra, Inc. has 1 recall in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.