Centurion I68505Recalls & reported problems
Centurion Medical Products Corporation · STERILE ROUND EAR SPECULUM SET (3, 4, 5) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Feb 23, 2024Open, Classified
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1433-2024 · Root cause: Process control · FDA record ↗
Other SPECULUM, ENT devices
- Sklar 96-2238Sklar Corporation · SPECULUM, ENT1 recall0 reports
- Sklar 96-2237MSklar Corporation · SPECULUM, ENT1 recall0 reports
- Sklar 96-2236Sklar Corporation · SPECULUM, ENT1 recall0 reports
- Integra® Jarit® 400143Integra Lifesciences Production Corporation · SPECULUM, ENT1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page