PlainRecalls

Outset Medical, Inc.

Compiled from official public sources by the publisher.

5 recalls on record · Latest: Oct 9, 2024

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Agency notice ledger

Federal filing book Outset Medical, Inc. LIGHT-BOOK · SINGLE-AGENCY

#2,598 of 14,151 · 5 notices · 0.005% archive

  • BOOK 5 notices
  • RANK #2,598 of 14,151
  • SHARE 0.005% archive
  • AGENCY FDA Devices (5)
  • CAT medical devices
  • CATS 1 category
  • LATEST Oct 9, 2024
  • PHOTO A G Specialty Foods I…

Nearest notice-volume peer: A G Specialty Foods Inc (0 notice gap)

Outset Medical, Inc. accounts for about 0.005% of the 104,423-notice archive on 5 distinct filings — a light share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Outset Medical, Inc. sits among 14,151 recalling firms

Outset Medical, Inc. ranks 2,598th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Outset Medical, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

5 2598th of 14151 higher than 11,411 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Outset Medical, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Outset Medical, Inc. holds about 0.005% of archive notices alongside 5 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Oct 9, 2024

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
FDA Devices Moderate Jun 26, 2024

TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
FDA Devices Critical Apr 24, 2024

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
FDA Devices Moderate Apr 19, 2023

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.
FDA Devices Moderate Mar 30, 2022

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

Outset Medical, Inc. is a small archive contributor

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Outset Medical, Inc.? ▼
PlainRecalls indexes 5 distinct federal recall events naming Outset Medical, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Outset Medical, Inc. sit among other recalling firms? ▼
Outset Medical, Inc. ranks #2,598 of 14,151 by distinct recall-event count among 14,151 firms in this archive (81st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Outset Medical, Inc.'s notices? ▼
FDA Devices accounts for 5 of this firm's 5 indexed notices.
What product category dominates Outset Medical, Inc.'s filing book? ▼
Filings for Outset Medical, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Outset Medical, Inc.: 5 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Outset Medical, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026