Penumbra recalls

Penumbra has 7 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 7 Oct 2026. 2 are still ongoing. 2 were reported in the last 12 months.

Total recalls7since 2017

Last 12 months2reported

Class I571% of total

Ongoing2latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 1 0 0Sep 1 0

Severity split

Class I 5 71%Class II 2 29%Class III 0 0%

Why penumbra is recalled

Other Reasons571%
Device Malfunction229%

Product types

Heart & Vascular Devices7100%

By year

2026229%
2021457%
2017114%

Ongoing penumbra recalls

2 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	System (RED 62 Reperfusion Catheter) recalled by Penumbra	Penumbra	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	System RED 68 Reperfusion Catheter recalled by Penumbra	Penumbra	Other	Nationwide

All penumbra recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	System (RED 62 Reperfusion Catheter) recalled by Penumbra	Penumbra	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	System RED 68 Reperfusion Catheter recalled by Penumbra	Penumbra	Other	Nationwide
27 Jan 2021Device	CLASS I	JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing recalled	Penumbra	Other	Nationwide
27 Jan 2021Device	CLASS I	JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX recalled	Penumbra	Other	Nationwide
27 Jan 2021Device	CLASS I	JET 7 Reperfusion Catheter recalled by Penumbra	Penumbra	Other	Nationwide
27 Jan 2021Device	CLASS I	JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing recalled	Penumbra	Other	Nationwide
26 Jul 2017Device	CLASS I	3D Revascularization Device It is indicated for used recalled	Penumbra	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.