Filing Flows › Outset Medical (OM) › Recalls, complaints & regulation
Outset Medical (OM): recalls
Outset Medical (OM) beyond its filings: 0 recalls in the last 12 months (5 in five years, 1 Class I).
Latest recalls
- 2024-10-09 · FDA device · 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
- 2024-06-26 · FDA device · TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords res
- 2024-04-24 · FDA device · Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
- 2023-04-19 · FDA device · Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System),
- 2022-03-30 · FDA device · Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Outset Medical's latest quarter
Outset Medical, Q3 2026: revenue $33.6M (+14% year over year), operating margin -36.5%, net loss $14.7M, operating cash flow −$10.4M. The chart follows the revenue to costs, profit and cash.
Questions
Has Outset Medical had any recalls?
5 recalls on file over five years from the FDA, CPSC and NHTSA; 0 in the last 12 months.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.