CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Emdogain; Article Numbers: 440.230V10, 475.132V10 recalled
Straumann USA is recalling Emdogain; Article Numbers: 440.230V10, 475.132V10, distributed nationwide in the US. The recall was initiated on 17 Oct 2025 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-0582-2026
- FDA event ID
- 97753
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Oct 2025
- FDA classified
- 21 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Oct 2025 | Recall initiated by company | |
| 21 Nov 2025 | Classified by FDA | +35 days |
| 3 Dec 2025 | 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
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Product as listed by the FDA
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Where it was distributed
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Nationwide ArizonaCaliforniaDelawareFloridaIdahoMissouriTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Which lots are affected?
1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
Where was it sold?
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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