RegWardenFDA facility compliance records
Facility

Outset Medical, Inc.

5 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2022: 1 recalls; 2023: 1 recalls, 1 inspections, 1 warning letters; 2024: 3 recalls, 1 inspections2017201820192020202112022320234202420252026
  • Recalls (5)
  • Inspections (2)
  • Warning letters (1)

Devices registered here (3)

  • Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Product code KDI (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5860
  • Subsystem, Water Purification
    Product code FIP (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5665
  • Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
    Product code FJK (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5820

Recalls & enforcement

  • Class IIOngoing2024-08-01
    Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experien…
  • Class IIOngoing2024-04-30
    A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or t…
  • Class IOngoing2024-03-06
    Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PC…
  • Class IIOngoing2023-01-24
    An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
  • Class IIOngoing2022-01-20
    Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

FDA inspections (2)

  • VAI2024-09-18
    Voluntary Action Indicated · Compliance: Devices
  • OAI2023-02-10
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Outset Medical, Inc. (FEI 3010355846) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010355846-outset-medical-inc/

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