Hemodialysis console blood leak sensor may fail to trigger alarm
A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a risk-of-harm condition (blood leak sensor malfunction in a hemodialysis system). Source text uses conditional language ("may show," "could delay," "if blood loss occurs") indicating no actual illnesses or injuries have been reported, meeting the criterion for a maximum score of 3.
Plain-English summary
Outset Medical is recalling 2,422 Tablo Hemodialysis consoles due to a blood leak sensor component that may show decreased sensitivity. Specifically, the sensor may fail to trigger the ALARM_DIALYZER_BLOOD_LEAK alarm when blood loss rates fall to the lowest specified level of 0.35 mL/min.
Hemodialysis patients depend on this alarm system to detect complications during treatment. If blood loss of less than 300ml occurs without the alarm activating, patients may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
The affected consoles have UDI-DI codes 00850001011112 and 00850001011204, with specific serial numbers listed in the official FDA recall notice. The devices were distributed across the United States and the United Arab Emirates. Patients currently using these systems should contact their healthcare provider to determine if their device is affected and to discuss next steps.
The recalled product
- Product
- 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.
- Manufacturer
- Outset Medical, Inc.
- Hazard
- blood-leak-sensor-failure
- alarm-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00850001011112
- 00850001011204. Serial Numbers: 400405
- 602382M
- 602384M
- 602387M
- 602400M
- 602402M
- 601124M
- 601156M
- 601102M
- 601265M
- 400109
- 602248M
- 602659M
- 602670M
- 602767M
- 602769M
- 602771M
- 601356M
- 602421M
Distribution
Distributed in 46 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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