Outset Medical recalls

Outset Medical has 5 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 9 Oct 2024. 5 are still ongoing.

Total recalls5since 2022

Last 12 months0reported

Class I120% of total

Ongoing5latest 9 Oct 2024

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 1 20%Class II 4 80%Class III 0 0%

Why outset medical is recalled

Product types

Other Medical Devices5100%

By year

2024360%
2023120%
2022120%

Ongoing outset medical recalls

5 active

Reported	Class	Recall	Company	Reason	Where
9 Oct 2024Device	CLASS II	Tablo Console recalled by Outset Medical	Outset Medical	Packaging Defects	46 states
26 Jun 2024Device	CLASS II	TabloCart with Prefiltration Drawer PN recalled by Outset Medical	Outset Medical	Lead & Heavy Metals	Nationwide
24 Apr 2024Device	CLASS I	Tablo Hemodialysis System recalled by Outset Medical	Outset Medical	Other	42 states
19 Apr 2023Device	CLASS II	Outset Tablo recalled by Outset Medical	Outset Medical	Device Malfunction	Nationwide
30 Mar 2022Device	CLASS II	Outset Tablo Console recalled by Outset Medical	Outset Medical	Other	Nationwide

All outset medical recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
9 Oct 2024Device	CLASS II	Tablo Console recalled by Outset Medical	Outset Medical	Packaging Defects	46 states
26 Jun 2024Device	CLASS II	TabloCart with Prefiltration Drawer PN recalled by Outset Medical	Outset Medical	Lead & Heavy Metals	Nationwide
24 Apr 2024Device	CLASS I	Tablo Hemodialysis System recalled by Outset Medical	Outset Medical	Other	42 states
19 Apr 2023Device	CLASS II	Outset Tablo recalled by Outset Medical	Outset Medical	Device Malfunction	Nationwide
30 Mar 2022Device	CLASS II	Outset Tablo Console recalled by Outset Medical	Outset Medical	Other	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.