Heraeus Medical GmbH (Dental Division)

Complete recall history across all FDA and CPSC categories — 4 total recalls

Heraeus Medical GmbH (Dental Division) 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 (4)

FDA medical device enforcement actions by Heraeus Medical GmbH (Dental Division)

Date Product Reason Class
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 ... increase of complaints regarding the breakage of the ampoules within their de... Class II
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/... increase of complaints regarding the breakage of the ampoules within their de... Class II
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Mode... increase of complaints regarding the breakage of the ampoules within their de... Class II
Dec 9, 2025 Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Mo... increase of complaints regarding the breakage of the ampoules within their de... 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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