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Heraeus Medical GmbH (Dental Division) FDA Recalls

6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Heraeus, PALAMIX uno. Material Number: 66057893.Class IIIMar 25, 2026Based on long-term stability testing, it was determined that
Heraeus, PALAMIX duo. Material Number: 66057897.Class IIIMar 25, 2026Based on long-term stability testing, it was determined that
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 SoftwarClass IIDec 9, 2025increase of complaints regarding the breakage of the ampoule
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Class IIDec 9, 2025increase of complaints regarding the breakage of the ampoule
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 SoftwClass IIDec 9, 2025increase of complaints regarding the breakage of the ampoule
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 SofClass IIDec 9, 2025increase of complaints regarding the breakage of the ampoule

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