Penumbra recalls

Penumbra has 6 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 29 Jul 2026. 1 is still ongoing. 1 was reported in the last 12 months.

Total recalls6since 2017

Last 12 months1reported

Class I583% of total

Ongoing1latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 5 83%Class II 1 17%Class III 0 0%

Why penumbra is recalled

Other Reasons583%
Lead & Heavy Metals117%

Product types

Heart & Vascular Devices6100%

By year

2026117%
2021467%
2017117%

Ongoing penumbra recalls

1 active

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	System RED 68 Reperfusion Catheter recalled by Penumbra	Penumbra	Other	Nationwide

All penumbra recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
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	Lead & Heavy Metals	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.