LivaNova Deutschland GmbH
Complete recall history across all FDA and CPSC categories — 5 total recalls
LivaNova Deutschland GmbH 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 LivaNova Deutschland GmbH
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 18, 2024 | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/perf... | Class II |
| Aug 3, 2023 | 3T Heater Cooler System, REF: 16-02-85 | The firm's labeling (Quick Reference Guide) contains incorrect information in... | Class II |
| Dec 17, 2021 | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... | One ferrite ring expected to be installed on centrifugal pump system power ca... | Class III |
| Aug 26, 2019 | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-... | The SCP control Panel rotary knob used to control rotary speed of the pump in... | Class II |
| Aug 26, 2019 | Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15,... | The SCP control Panel rotary knob used to control rotary speed of the pump in... | 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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