Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tablo Console Recalled by Outset Medical, Inc. Due to Blood leak sensor, a component of hemodialysis device,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Outset Medical, Inc. directly.
Affected Products
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.
Quantity: 2,422
Why Was This Recalled?
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 experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
Where Was This Sold?
This product was distributed to 46 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY
About Outset Medical, Inc.
Outset Medical, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report