Heraeus Medical GmbH is recalling approximately 52,896 PALAMIX uno and PALAMIX duo dental mixing devices because long-term stability testing revealed the mixing rod can come loose from its lock during use in units older than 17 months. As a result, the manufacturer is reducing the product's shelf life from 3 years down to 1.5 years (17 months) to ensure safety. Consumers should check their inventory for these specific dental material mixing systems and contact the manufacturer to arrange for a return or replacement of any units that have exceeded the new 1.5-year age limit.
In rare cases, the mixing rod may detach from its lock during the mixing process if the unit is older than 17 months, which could lead to improper mixing of dental materials or device failure during a procedure.
All batches with numbers below 223060.
All batches with numbers below 520215.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.