Outset Medical, Inc.
Outset Medical, Inc. has 5 FDA enforcement events on this register (5 product records) between 2022 and 2024: 5 device; the busiest year was 2024 with 3.
20% of its events are Class I; the most common class is Class II (4). 5 events are listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
By type and class
Class I: 20% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Outset Medical, Inc. had?
5 enforcement events (5 product records) on this register, 2022–2024: 5 device.
Are any Outset Medical, Inc. recalls ongoing?
5 events are listed as ongoing in the current openFDA export.
What class are Outset Medical, Inc. recalls?
4 Class II, 1 Class I. 20% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.