Heraeus PALAMIX duo dental mixing system batches worldwide recall
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The source text explicitly indicates no illnesses or injuries have been reported, and the hazard is preventable through shelf-life compliance rather than an inherent product defect.
Plain-English summary
Heraeus Medical GmbH (Dental Division) is recalling approximately 1,125 units of the PALAMIX duo dental mixing system (Material Number 66057897, UDI-DI: 04260102133617). The recall affects all batch numbers below 520215.
Based on long-term stability testing, Heraeus 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. The product's shelf life is being reduced from 3 years to 1.5 years (17 months) as a result.
The product has been distributed worldwide, including throughout the US and internationally to Austria, Belgium, Brazil, Chile, China, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Thailand, United Kingdom, and other countries listed by the FDA.
Customers in possession of units should verify the age of their product and adhere to the new 1.5-year shelf life limit to prevent potential mixing failures during use.
The recalled product
- Product
- Heraeus, PALAMIX duo. Material Number: 66057897.
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Affected units
- 1,125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Material Number: 66057897
- UDI-DI: 04260102133617
- Batch: all batches with numbers below 520215
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Heraeus Medical GmbH (Dental Division) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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