PlainRecalls

LivaNova USA

Compiled from official public sources by the publisher.

5 recalls on record · Latest: Jan 30, 2019

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Agency notice ledger

Federal filing book LivaNova USA LIGHT-BOOK · SINGLE-AGENCY

#2,541 of 14,151 · 5 notices · 0.005% archive

  • BOOK 5 notices
  • RANK #2,541 of 14,151
  • SHARE 0.005% archive
  • AGENCY FDA Devices (5)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jan 30, 2019
  • PHOTO A G Specialty Foods I…

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

LivaNova USA 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 →

LivaNova USA's standing among 14,151 recalling firms

LivaNova USA ranks 2,541st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

LivaNova USA vs all firms by recall-notice count

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

5 2541st 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 · 2026-10-09

LivaNova USA in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows LivaNova USA holds about 0.005% of archive notices alongside 5 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of October 2026
FDA Devices Moderate Jan 30, 2019

Perfusion Pack, Rx only, Sterile EO
FDA Devices Moderate May 30, 2018

Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy
FDA Devices Moderate May 30, 2018

Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy

FDA Devices Moderate May 30, 2018

Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
FDA Devices Low Feb 28, 2018

Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.

LivaNova USA 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 LivaNova USA? ▼
PlainRecalls indexes 5 distinct federal recall events naming LivaNova USA, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of October 2026). That count is an issuance inventory, not a hazard score.
Where does LivaNova USA sit among other recalling firms? ▼
LivaNova USA ranks #2,541 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 LivaNova USA's notices? ▼
FDA Devices accounts for 5 of this firm's 5 indexed notices.
What product category dominates LivaNova USA's filing book? ▼
Filings for LivaNova USA 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.
LivaNova USA: 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 LivaNova USA; individual notices remain authoritative on each linked recall page.

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