Heraeus — Class III medical device recall Z-1998-2026
Ongoing recall by Heraeus Medical GmbH (Dental Division), reported 2026-05-06, distributed nationwide. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mix
| Recall number | Z-1998-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heraeus Medical GmbH (Dental Division), Wehrheim, Germany |
| Recall initiated | 2026-03-25 |
| Classified | 2026-04-29 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CH, CL, CN, CY, CZ, DE, DK, DZ, EC, ES, FI, FR, GB, GR, HU, IE, IL, IN, IT, KR, LT, LU, MT, MX, MY, NG, NL, NO, PE, PH, PL, PT, SA, SE, SG, SI, SK, TH, UY, ZA |
| Quantity | 1,125 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 04260102133617 |
Product
Heraeus, PALAMIX duo. Material Number: 66057897.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1998-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.