CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Palacos MV pro recalled by Heraeus Medical GmbH (Dental
Heraeus Medical GmbH (Dental Division) is recalling Palacos MV pro 40, distributed nationwide in the US. The recall was initiated on 20 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3304-2026
- FDA event ID
- 99708
- Recalling firm
- Heraeus Medical GmbH (Dental Division), Wehrheim
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2026
- FDA classified
- 25 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2026 | Recall initiated by company | |
| 25 Sep 2026 | Classified by FDA | +36 days |
| 7 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for monomer liquid leakage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential for monomer liquid leakage.
Which lots are affected?
Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99708This product is part of a recall event; the main page for the event is Palacos MV+G pro recalled by Heraeus Medical GmbH (Dental.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Palacos MV+G pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide | |
| CLASS II | Palacos R+G pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide | |
| CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
More recalls from Heraeus Medical GmbH (Dental Division)
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Palacos R+G pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Palacos MV+G pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS III | Heraeus, Palamix duo recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Potency & Assay | Nationwide |
| Device | CLASS III | Heraeus, Palamix uno recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Potency & Assay | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |