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Heraeus Medical GmbH (Dental Division) recall records

6 reported ongoing

6 records in this archive. Latest source date Mar 25, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 the shelf life from 3 years to 1.5 years ...

Class IIIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador,...

Official source
FDA device enforcement

Heraeus, PALAMIX duo. Material Number: 66057897.

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 the shelf life from 3 years to 1.5 years ...

Class IIIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador,...

Official source
FDA device enforcement

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 me...

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 un...

Class IIReported ongoing

Distribution: International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Por...

Official source
FDA device enforcement

Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methy...

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 un...

Class IIReported ongoing

Distribution: International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Por...

Official source
FDA device enforcement

Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(met...

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 un...

Class IIReported ongoing

Distribution: International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Por...

Official source
FDA device enforcement

Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl ...

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 un...

Class IIReported ongoing

Distribution: International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Por...

Official source

Reasons in these listed records

  • 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 the shelf life from 3 years to 1.5 years (17 months).
  • 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. ...

These examples come from this result page and are not a ranking of every recall reason.

Checking Heraeus Medical GmbH (Dental Division)

Is there a recall on heraeus medical gmbh (dental division) right now?

This archive contains 6 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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