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Outset Medical, Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Outset Medical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Outset Medical, Inc.

Date Product Reason Class
Aug 1, 2024 Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis Sy... Blood leak sensor, a component of hemodialysis device, may show decreased sen... Class II
Apr 30, 2024 TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 ... A cart with prefiltration drawer, an optional hemodialysis system accessory, ... Class II
Mar 6, 2024 Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, wi... Class I
Jan 24, 2023 Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a ne... An observed trend of high conductivity dialysate alarms in a hemodialysis sys... Class II
Jan 20, 2022 Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 Due to a component in the hemodialysis console there is the possibility of he... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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