Recall company profile

Heraeus Medical GmbH (Dental Division) Recalls

Overview of recall records associated with Heraeus Medical GmbH (Dental Division), including dates, categories and classifications where available.

6recall records
May 6, 2026latest record date
Jan 21, 2026earliest record date

Recall history in this database

Classification mix: Class II: 4, Class III: 2.

Medical DeviceMay 6, 2026

Heraeus Medical GmbH Heraeus, PALAMIX uno recall — FDA Z-1997-2026

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process.…

Class IIIFDA: OngoingHeraeus Medical GmbH (Dental Division)
Medical DeviceMay 6, 2026

Heraeus Medical GmbH Heraeus, PALAMIX duo recall — FDA Z-1998-2026

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process.…

Class IIIFDA: OngoingHeraeus Medical GmbH (Dental Division)
Medical DeviceJan 21, 2026

PALACOS R+G pro 40; PALACOS R+G pro 80 recall — FDA Z-1081-2026

increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage.…

Class IIFDA: OngoingHeraeus Medical GmbH (Dental Division)
Medical DeviceJan 21, 2026

PALACOS MV pro 40; PALACOS MV pro 80 recall — FDA Z-1083-2026

increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage.…

Class IIFDA: OngoingHeraeus Medical GmbH (Dental Division)
Medical DeviceJan 21, 2026

PALACOS R pro 40; PALACOS R pro 80 recall — FDA Z-1080-2026

increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage.…

Class IIFDA: OngoingHeraeus Medical GmbH (Dental Division)
Medical DeviceJan 21, 2026

PALACOS MV+G pro 40; PALACOS MV+G pro 80 recall — FDA Z-1082-2026

increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage.…

Class IIFDA: OngoingHeraeus Medical GmbH (Dental Division)

Understanding this recall history

This page summarizes recall records in which the official source identifies Heraeus Medical GmbH (Dental Division) as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.