Stryker SCT40Recalls & reported problems
Terragene S.A. · Sterizone Sealing Tape · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07798164678205), received between Dec 27, 2023 and Dec 27, 2023 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AN IMPORTER REPRESENTATIVE INFORMED OF OPENED TWO TAPES AND THEY TURNED GREEN IN THE CONFERENCE ROOM OF A HOTEL WITH NO CHEMICAL PRESENCE AND A MINIMAL LIGHT EXPOSURE, AS THEY WERE STORED PRIMARLY IN THEIR PACKAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18397025 ↗
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- 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.