Fresh Recalls

FDAClass II · Medical device · Recall Z-3304-2026 · Recalled October 7, 2026

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

Agency report date: October 7, 2026.

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 MV pro 40
Company / brand
Heraeus Medical (Dental Division)
Lot / serial / date codes
Lot Code: UDI-DI: 04260102135338; 04260102135369. 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 MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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). Component: N/A

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.

2. Agency hazard and consumer action

FDA reports: Potential for monomer liquid leakage.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: PALACOS MV pro 40 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-3304-2026
Brand
All Heraeus Medical (Dental Division) recalls
Classification
Class II
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Wehrheim, Germany
Firm address
Philipp-Reis-Str. 8, N/A

Identifying details (verbatim from the notice)

Product codes / lots
Lot Code: UDI-DI: 04260102135338; 04260102135369. 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.
Firm notified the public via
E-Mail
FDA event ID
99708
Recall initiated
August 20, 2026
FDA classified
September 25, 2026
FDA report date
October 7, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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