PALACOS R pro 40: recall status

Notice names this product. Heraeus Medical (Dental Division)’s PALACOS R pro 40 is named in FDA Class II recall Z-3301-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Potential for monomer liquid leakage. Identifying details: UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.. Units affected: 33,727 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: PALACOS R pro 40
Company / brand: Heraeus Medical (Dental Division)
Lot / serial / date codes: UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.
Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

Agency product description and boundaries

PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Heraeus Medical (Dental Division)

Recalls naming this model

FDA Class II · Medical device · October 7, 2026

PALACOS R pro 40 recall — Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

Company / brand: Heraeus Medical (Dental Division) recalls

Affected product: PALACOS R pro 40 recall status

Official ID Z-3301-2026 · Official record ↗

See all Heraeus Medical (Dental Division) recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.