Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a Recalled by Outset Medical, Inc. Due to An observed trend of high conductivity dialysate alarms...
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
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
Quantity: 374 systems
Why Was This Recalled?
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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