Outset Medical recalls
Outset Medical appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2024-10-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System
FDA Device · Class II · 2024-10-09 · Outset Medical - TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
FDA Device · Class II · 2024-06-26 · Outset Medical - Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
FDA Device · Class I · 2024-04-24 · Outset Medical - Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System…
FDA Device · Class II · 2023-04-19 · Outset Medical - Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
FDA Device · Class II · 2022-03-30 · Outset Medical