Outset Medical, Inc.: FDA recalls
FDA enforcement events from 2022 to 2024; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.
FDA enforcement reports name Outset Medical, Inc. as the recalling firm in 5 events. The events have 5 product records. The recalls started from 2022 to 2024. All the events are device recalls. By FDA enforcement events, Outset Medical, Inc. is number 679 of 1,628 firms that have a page. Events that Outset Medical, Inc. started: 3 in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 80.0% of its events and 73.7% of all FDA events.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
5 events, newest first.
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Type and class
| Type | Events |
|---|---|
| Device | 5 |
| Class | Events |
|---|---|
| Class II | 4 |
| Class I | 1 |
- Share of the events of the firm in Class I
- 20%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 5
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. Outset Medical, Inc.: FDA recalls. https://recallregister.com/firm/outset-medical-inc/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 3 Nov 2026
- State of the firm address
- CA
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of Outset Medical, Inc. have?
- Class II: 4 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of Outset Medical, Inc.?
- FDA event 95294, which the firm started on 1 Aug 2024. The first product in the record is:
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
- How many FDA recalls of Outset Medical, Inc. have the status Ongoing?
- 5 events have the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.