The FDA announced on April 30, 2024, that Outset Medical is recalling TabloCart units with Prefiltration Drawer PN-0006813 due to a thermal event hazard. The agency stated the recall involves specific power cords and affects 431 units distributed nationwide.
How to tell if you have it
- Brand: Outset Medical
- Product: TabloCart with Prefiltration Drawer PN-0006813
- Power Cord PN-0005746 (10-foot)
- Power Cord PN-0006578 (15-foot)
- Power Cord PN-0005747 (20-foot)
- UDI-DI: 00850001011303
- Units affected: 431
The hazard
According to the FDA, the cart's female connector internal contact pins may become damaged, creating localized heat, sparks, smoke, melting or charring. This thermal event could lead to a transient delay in treatment or blistering to the user.
Context
GovInfoNow's records show Outset Medical, Inc. has had 4 other recalls on record since January 20, 2022. Other recent recalls of similar products include Medline Full Electric Low Lightweight Bed Recall (November 26, 2025), Medline beds recall (November 26, 2025) and Medline Beds Recall (November 26, 2025).