Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1997-2026 — Heraeus, PALAMIX uno. Material Number: 66057893.

U.S. FDA — Device Enforcement · Germany · 2026-03-25 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1997-2026
Date of alert
2026-03-25
Country / jurisdiction
Germany
Risk level
Class III
Risk type
recall
Brand
Heraeus Medical GmbH (Dental Division)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
66057893
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.