Heraeus Medical recalls
3 official recalls and safety alerts involving Heraeus Medical since 2026-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Heraeus Medical or the relevant agency.
- 2026-10-07
USHeraeus Medical GmbH (Dental Division) recalls PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl…
Potential for monomer liquid leakage.
FDA · DeviceHeraeus Medical GmbH (Dental Division)Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice →- 2026-05-06
- US
Heraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX uno. Material Number: 66057893.
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. Notification is to reduce…
FDA · DeviceHeraeus Medical GmbH (Dental Division)Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - 2026-01-21
- US
Heraeus Medical GmbH (Dental Division) recalls Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software…
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. An unfortunate combination of…
FDA · DeviceHeraeus Medical GmbH (Dental Division)International distribution in the countries of Aland Islands, Australia,…Official notice →