Heraeus Medical GmbH (Dental Division) 2026-01-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1081-2026
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog… Recall
Issued January 21, 2026 · Heraeus Medical GmbH (Dental Division)
In January 2026, Heraeus Medical GmbH (Dental Division) recalled the Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
What you should do
- 1 Stop using Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Heraeus Medical GmbH (Dental Division) to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Heraeus Medical GmbH (Dental Division)
- Category
- Health
- Recall date
- January 21, 2026
- Units affected
- Not reported
- Sold at
- International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein,
- Recall number
- FDA-Z-1081-2026
- Made in
- Germany
- Issuing agency
- FDA
In context
- Heraeus Medical GmbH (Dental Division) has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.