Palodex Group Oy
Complete recall history across all FDA and CPSC categories — 5 total recalls
Palodex Group Oy 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 Palodex Group Oy
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 28, 2021 | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray... | It was noticed in production on 28.10.2021, that the final testing database g... | Class II |
| Jan 7, 2020 | KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA ... | Class II |
| Jan 7, 2020 | Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA ... | Class II |
| Jan 7, 2020 | Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA ... | Class II |
| Jan 7, 2020 | Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL I... | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA ... | 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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