Stop using nowMedical device recall · FDA · Published July 24, 2026
Penumbra RED 62 Reperfusion Catheter Recall: Risk of Fracture
Penumbra recalls 43 RED 62 Reperfusion Catheters due to potential fracture from manufacturing issues. Affected units sold nationwide in specific states. Stop using immediately.
“Penumbra RED 62 Reperfusion Catheter Recall: Risk of Fracture.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449513-penumbra-inc-recalls-brand-name-penumbra-system-red-62-reperfusion. Based on FDA recall #Z-3331-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3331-2026%22&limit=1).
Penumbra Inc. voluntarily recalled the Penumbra System (RED 62 Reperfusion Catheter) due to potential fracture from manufacturing issues, according to a July 24, 2026 Food and Drug Administration announcement.
How to tell if you have it
Brand: Penumbra
Product Name: Penumbra System (RED 62 Reperfusion Catheter)
Model/Catalog Number: THNDRRED62SKIT
Lot Number: H00007856
UDI: 00815948024359
The hazard
Due to manufacturing issues, the reperfusion catheters may fracture.
Context
GovInfoNow's records show Penumbra Inc. has issued three other recalls since June 9, 2017. On June 3, 2026, the company recalled the Penumbra RED 68 Reperfusion Catheter for similar fracture risks. Other recent recalls of similar products include Medline Urethral Catheter Tray Recall (May 4, 2026), B. Braun Medical SESK UPMC Double Catheter Tray Recall (Jan. 29, 2026), and Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026).
How to tell if you have this one
Check for the model number THNDRRED62SKIT on the catheter packaging. The lot code UDI: 00815948024359 and lot number H00007856 identify affected units. These catheters were distributed in specific U.S. states.
Brand
Penumbra
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop using it now
Immediately stop using the Penumbra RED 62 Reperfusion Catheter if it has the model number THNDRRED62SKIT and lot code UDI: 00815948024359.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Louisiana, New York, North Carolina, Texas, Utah, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3331-2026 (July 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3331-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.