StrykerRecalls & reported problems across all models
Terragene S.A. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Stryker by Terragene S.A. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 26, 2023 and Jan 10, 2024 — classified as 29 malfunctions.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Stryker problems
Device problems
- Appropriate Device Problem Term/Code Not Available29
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Stryker models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stryker SLCD12Indicator, Biological Sterilization Process15 reports
- Stryker SRBI30Indicator, Biological Sterilization Process12 reports
- Stryker SCT40Indicator, Physical/Chemical Sterilization Process1 report
- Stryker SCIRYIndicator, Physical/Chemical Sterilization Process1 report
Recent Stryker adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE WERE RECURRING BIS FOLLOWING COMPLETED VP4 CYCLES. THE VP4 DID NOT REGISTER ANY ERROR CODES OR CANCEL ANY LOADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18485754 ↗MalfunctionJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE USER, THE AUTO-READER INCUBATOR KEPT SHOWING POSITIVE RESULTS FOR THE BIOLOGICAL INDICATORS AFTER THE STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18482956 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
SALES REPRESENTATIVE REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18478140 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DISTRIBUTOR REPORTED THE BIOLOGICAL INDICATOR IS SHOWING POSITIVE RESULTS AFTER THE STERILIZATION PROCESES, NOT ALLOWING THE LOADS TO BE RELEASED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18477203 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE CUSTOMER THAT THE INCUBATOR HAS SOME PORTS NOT WORKING PROPERLY. THE DEVICE WAS SENT BACK TO THE DISTRIBUTOR BUT NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475644 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE USER, THE AUTOREADER WAS BROKEN. NOTICED DURING TESTING. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475002 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE USER, THE AUTOREADER INCUBATOR WAS NOT WORKING DURING TESTING. PRODUCT WAS SCRAPPED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474940 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE AUTOREADER INCUBATOR'S TOUCH SCREEN WAS UNRESPONSIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474830 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE USER, THE INCUBATOR WOULD NOT TURN ON. NOTICED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474341 ↗MalfunctionJan 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE WERE RECURRING BIS FAILING FOLLOWING COMPLETED VP4 CYCLES. THE VP4 DID NOT REGISTER ANY ERROR CODES OR CANCEL ANY LOADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18467518 ↗MalfunctionJan 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER REPORTED THAT THE CHEMICAL INDICATORS WERE UNUSABLE RIGHT OUT OF THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18467505 ↗MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
SALES REPRESENTATIVE REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446634 ↗MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18445432 ↗MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER REPORTED AUTOREADER MALFUNCTION BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18444255 ↗MalfunctionJan 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18437800 ↗
Other Terragene S.A. products
All Terragene S.A. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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