Penumbra Inc. recalls
Every recall we track for Penumbra Inc. — 7 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Penumbra Inc. peaked in 2020 (4); 7 since 2017. 43% rated “stop using now”.
All FDA recall records for Penumbra Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 0 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 3 | 0 | 0 | 4 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 1 | 1 | 0 | 0 | 2 |
What to do if you have a recalled Penumbra Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Penumbra Inc. recalls
4 shown- Stop using nowMedical device
Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter)
Penumbra recalls 43 RED 62 Reperfusion Catheters due to potential fracture from manufacturing issues. Affected units sold nationwide in specific states. Stop using immediately.
PenumbraJul 24, 2026 - Use cautionMedical device
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra recalls RED 68 Reperfusion Catheters with potential fracture risk due to manufacturing issues. Affected units include specific UDI and lot numbers.
PenumbraJun 3, 2026 - Use cautionMedical device
Penumbra Inc. recalls Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7
Penumbra recalls JET 7 Reperfusion Catheter kits due to potential distal tip damage during use that could cause vessel injury or death if contrast injection pressure is applied.
PenumbraDec 15, 2020 - Stop using nowMedical device
Penumbra Inc. recalls Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic
Penumbra recalls four lots of 3D Revascularization Devices due to potential delivery wire breakage causing serious injury or death during acute stroke treatment.
PenumbraJun 9, 2017
Penumbra Inc. recall questions
How many recalls has Penumbra Inc. had?
7 recalls from Penumbra Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Penumbra Inc. recall?
Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter), dated Jul 24, 2026. Every Penumbra Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Penumbra Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Penumbra Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.