HeartSine Technologies Ltd
Complete recall history across all FDA and CPSC categories — 6 total recalls
HeartSine Technologies Ltd 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 (6)
FDA medical device enforcement actions by HeartSine Technologies Ltd
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 18, 2025 | HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-P... | Due to customer complaints, defibrillator pads may contain damage pins that d... | Class II |
| Jun 30, 2025 | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The Hea... | Due to a component manufacturing issue, Automated External Defibrillator may ... | Class II |
| Apr 8, 2024 | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 36... | Automated external defibrillators have a manufacturing issue that could preve... | Class II |
| Feb 14, 2024 | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... | Automated external defibrillators were shipped in their test configuration so... | Class II |
| Apr 26, 2023 | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate... | Single use battery and electrode cartridge may be rendered inoperable due to ... | Class II |
| Feb 1, 2023 | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P ful... | Automated external defibrillators were potentially distributed with the incor... | 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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