Heraeus Medical GmbH (Dental Division) recalls
Every recall we track for Heraeus Medical GmbH (Dental Division) — 10 in all, from 2025–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Heraeus Medical GmbH (Dental Division) peaked in 2025 (4); 10 since 2017.
All FDA recall records for Heraeus Medical GmbH (Dental Division) since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 4 | 0 | 4 |
| 2026 (to date) | 0 | 1 | 2 | 3 | 6 |
Most common reasons for Heraeus Medical GmbH (Dental Division) recalls
What to do if you have a recalled Heraeus Medical GmbH (Dental Division) product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Heraeus Medical GmbH (Dental Division) recalls
3 shown- Use cautionMedical device
Heraeus Medical GmbH (Dental Division) recalls PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl
Heraeus Medical recalls PALACOS MV+G pro 40 dental bone cement (model 5081290) due to potential monomer leakage. All units sold worldwide from 2026-08-20 are affected. Return or stop use immediately.
Heraeus MedicalAug 20, 2026 - Lower riskMedical device
Heraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX uno. Material Number: 66057893.
Heraeus recalls PALAMIX uno dental mixers with material number 66057893 that may have a mixing rod that comes loose after 17 months of use. Reduce shelf life from 3 years to 1.5 years.
HeraeusMar 25, 2026 - Lower riskMedical device
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
Heraeus Medical recalls PALACOS R+G pro 40 and 80 dental cement models due to risk of unbreakable ampoules causing improper cement application. Affected units may not form proper cement dough for patients.
PALACOSDec 9, 2025
Heraeus Medical GmbH (Dental Division) recall questions
How many recalls has Heraeus Medical GmbH (Dental Division) had?
10 recalls from Heraeus Medical GmbH (Dental Division) are on record with U.S. safety agencies, from 2025–2026.
What is the most recent Heraeus Medical GmbH (Dental Division) recall?
Heraeus Medical GmbH (Dental Division) recalls PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl, dated Aug 20, 2026. Every Heraeus Medical GmbH (Dental Division) recall is listed on this page, newest first.
Why are Heraeus Medical GmbH (Dental Division) products recalled?
The most common reasons on record: Potential for monomer liquid leakage. (4).
What should I do if I have a recalled Heraeus Medical GmbH (Dental Division) product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Heraeus Medical GmbH (Dental Division) recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.