DH Nyclave Indicator Labels 116312Recalls & reported problems
Young Dental Manufacturing I, LLC · Dry Heat sterilization indicators · Class 2
Data updated Oct 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Dec 29, 2021Class IIOpen, Classified
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Z-0555-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Indicator, Physical/Chemical Sterilization Process devices
- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall5 reports
- VERIFY PCC006Albert Browne Limited · Indicator, physical/chemical sterilization process1 recall0 reports
- STEAM INDICTR STRIP SIS-250SPS Medical Supply Corp. · Indicator, physical/chemical sterilization process1 recall0 reports
- 3M™ Attest™ 1243A3m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- Integron® PCD26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- VERIFY SixCess LCC003Steris Corporation · Indicator, physical/chemical sterilization process1 recall0 reports
- STEAMPLUS STERILIZATION INTEGRATOR SSI-1000Crosstex International, Inc. · Indicator, physical/chemical sterilization process1 recall0 reports
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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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