Lower riskMedical device recall · FDA · Published March 25, 2026
Heraeus PALAMIX uno: Mixing rod may come loose after 17 months of use
Heraeus recalls PALAMIX uno dental mixers with material number 66057893 that may have a mixing rod that comes loose after 17 months of use. Reduce shelf life from 3 years to 1.5 years.
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).
Take action
Contact the company
📍Recalling firmHeraeus Medical GmbH (Dental Division)Philipp-Reis-Str. 8 · Wehrheim, Germany
“Heraeus PALAMIX uno: Mixing rod may come loose after 17 months of use.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49599-heraeus-palamix-uno-mixing-rod-may-come-loose-after-17. Based on FDA recall #Z-1997-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1997-2026%22&limit=1).
The FDA announced on March 25, 2026, that Heraeus Medical GmbH (Dental Division) is recalling Heraeus and PALAMIX uno products due to a potential mixing rod failure. The agency issued recall number Z-1997-2026 for the voluntary Class III action affecting worldwide distribution.
How to tell if you have it
Brand: Heraeus
Product: Heraeus, PALAMIX uno
Material Number: 66057893
UDI-DI: 04260102133587
Batch: all batches with numbers below 223060
The hazard
Long-term stability testing determined that in units older than 1.5 years (17 months), the mixing rod may come loose from its lock during the mixing process. The notification reduces the shelf life from 3 years to 1.5 years (17 months).
Context
GovInfoNow's records show Heraeus Medical GmbH (Dental Division) has two other recalls on record since December 9, 2025. Other recent recalls of similar products include PALACOS MV+G pro 40/80 Dental Cement Recall (2025-12-09), Heraeus PALACOS R pro 40 and 80 recall (2026-08-20), Stryker Hoffmann II Connecting Rod Micro 3 x 50mm recall (2026-07-01), Zimmer Disposable Mixing Bowls with Spatula Recall (2026-03-30), and Stryker Hoffmann II Connecting Rod Micro 3 x 120mm recall (2026-07-01).
How to tell if you have this one
Check for the material number 66057893 on the PALAMIX uno mixer. Units older than 17 months (1.5 years) with this material number are affected.
Brand
Heraeus
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;
Recall number
Product, codes & lots
Quantity
Z-1997-2026
Heraeus, PALAMIX uno. Material Number: 66057893.; Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060;
51,771 units
Z-1998-2026
Heraeus, PALAMIX duo. Material Number: 66057897.; Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
1,125 units
Based on the official FDA remedy
What to do — step by step
Check Product Date
Verify the material number is 66057893 and the mixer has been in use for more than 17 months.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1997-2026 (March 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1997-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.