RegWardenFDA facility compliance records
Company

Heraeus Medical GmbH

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2025: 1 recalls; 2026: 1 recalls201720182019202020212022202320241202512026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIIOngoing2026-03-25
    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).
  • Class IIOngoing2025-12-09
    increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If …

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Heraeus Medical GmbH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10048423-heraeus-medical-gmbh/

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