Heraeus Medical GmbH (Dental Division): FDA recalls
FDA enforcement events from 2025 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.
FDA enforcement reports name Heraeus Medical GmbH (Dental Division) as the recalling firm in 3 events. The events have 10 product records. The recalls started from 2025 to 2026. All the events are device recalls. By FDA enforcement events, Heraeus Medical GmbH (Dental Division) is number 1,109 of 1,626 firms that have a page. Events that Heraeus Medical GmbH (Dental Division) started: none in 2024 and 1 in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,772 in 2024 to 1,836 in 2025.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
3 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 20 Aug 2026 | PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). | Device | Class II | 4 | Ongoing |
| 25 Mar 2026 | Heraeus, PALAMIX uno. Material Number: 66057893. | Device | Class III | 2 | Ongoing |
| 9 Dec 2025 | Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to… | Device | Class II | 4 | Ongoing |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
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Type and class
| Type | Events |
|---|---|
| Device | 3 |
| Class | Events |
|---|---|
| Class II | 2 |
| Class III | 1 |
- Share of the events of the firm in Class I
- 0%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 3
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. Heraeus Medical GmbH (Dental Division): FDA recalls. https://recallregister.com/firm/heraeus-medical-gmbh-dental-division/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of Heraeus Medical GmbH (Dental Division) have?
- Class II: 2 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of Heraeus Medical GmbH (Dental Division)?
- FDA event 99708, which the firm started on 20 Aug 2026. The first product in the record is:
PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).
- How many FDA recalls of Heraeus Medical GmbH (Dental Division) have the status Ongoing?
- 3 events have the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.