Flyte, SurgiCool 0408801400Recalls & reported problems
Stryker Corporation · Hood · Class 2
All models of Flyte, SurgiCool (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613252661078), received between Nov 12, 2018 and Jul 29, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product3
- Device Contaminated During Manufacture or Shipping3
- Device Contamination with Chemical or Other Material2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DEVICE CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647059 ↗MalfunctionJan 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200849 ↗MalfunctionOct 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20504462 ↗MalfunctionJul 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823079 ↗MalfunctionJan 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556790 ↗MalfunctionOct 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17992793 ↗MalfunctionJan 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS CONTAMINATED WITH A CHEMICAL OR OTHER MATERIAL. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261774 ↗MalfunctionJul 26, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS CONTAMINATED WITH A CHEMICAL OR OTHER MATERIAL. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15101963 ↗MalfunctionNov 12, 2018Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, PATIENT FLUID SOAKED THROUGH THE HOOD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8060457 ↗
Other HOOD, SURGICAL devices
- Flyte, SurgiCool 0408801500Stryker Corporation · HOOD, SURGICAL7 reports
- T7 0416-800-200Stryker Corporation · HOOD, SURGICAL5 reports
- T7Plus 0416-801-100Stryker Corporation · HOOD, SURGICAL3 reports
- T7Plus 0416-801-200Stryker Corporation · HOOD, SURGICAL3 reports
- T7Plus 0416-801-000Stryker Corporation · HOOD, SURGICAL2 reports
- T7 0416-800-100Stryker Corporation · HOOD, SURGICAL2 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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