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Heraeus Medical GmbH (Dental Division) recalls

The FDA has posted 10 enforcement recalls from Heraeus Medical GmbH (Dental Division) since 2025, none of them Class I (most serious). Most recent report: Oct 7, 2026.

Class II: 8Class III: 2

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Class IIIOngoingZ-1997-2026

Heraeus Medical GmbH (Dental Division) recalls Heraeus

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.…

  • For Clinical Use Cement Mixer
  • Under Investigation by firm
Heraeus Medical GmbH (…May 6, 2026
Class IIIOngoingZ-1998-2026

Heraeus Medical GmbH (Dental Division) recalls Heraeus

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.…

  • For Clinical Use Cement Mixer
  • Under Investigation by firm
Heraeus Medical GmbH (…May 6, 2026

Firm name as filed with the FDA: “Heraeus Medical GmbH (Dental Division)”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.