STEAMPLUS STERILIZATION INTEGRATOR SSI-1000Recalls & reported problems
Crosstex International, Inc. · Wicking-style device that verifies when all critical parameters of steam sterilization have been met during a sterilizer cycle. · Class 2
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
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1792-2022 · Root cause: Environmental control · FDA record ↗
Other Indicator, physical/chemical sterilization process devices
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- 3M™ Attest™ 1243A3m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- 3M™ Attest™ 1243B3m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- DH Nyclave Indicator Labels 116312Young Dental Manufacturing I, LLC · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- Comply™ 12483m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- Comply™ 12483m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.