Drug & Device Safety Atlas

FDA recall record · openFDA

Outset Medical, Inc.

4 FDA recalls on record (2023–2024) — 4 device. 4 still ongoing.

1
Class I (most serious)
3
Class II
0
Class III
4
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be repla 1
Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 1
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software t 1
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has 1

Recalls

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Class I 2024-03-06 Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi Class II 2024-08-01 TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 Class II 2024-04-30 Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis Class II 2023-01-24

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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