Flyte, SurgiCoolRecalls & reported problems across all models
Stryker Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 7 models of Flyte, SurgiCool by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2018 and Jul 29, 2025 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (13 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. 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 Flyte, SurgiCool problems
Device problems
- Material Split, Cut or Torn13
- Device Contaminated During Manufacture or Shipping6
- Material Integrity Problem5
- Delivered as Unsterile Product4
- Device Contamination with Chemical or Other Material4
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient13
- No Patient Involvement3
Flyte, SurgiCool models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flyte, SurgiCool 0408801400HOOD, SURGICAL9 reports
- Flyte, Surgicool 0408741000GOWN, SURGICAL8 reports
- Flyte, SurgiCool 0408801500HOOD, SURGICAL7 reports
- Flyte, Surgicool 0408731000GOWN, SURGICAL4 reports
- Flyte, Surgicool 0408721000GOWN, SURGICAL1 report
- Flyte, SurgiCool 0408841000GOWN, SURGICAL1 report
- Flyte, SurgiCool 0408841100GOWN, SURGICAL1 report
Recent Flyte, SurgiCool adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 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 21878603 ↗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 DURING A NON-CLINICAL PROCEDURE. -THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200855 ↗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; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823130 ↗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 ↗MalfunctionOct 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS CONTAMINATED WITH A CHEMICAL OR OTHER MATERIAL. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17991009 ↗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 ↗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 15101946 ↗MalfunctionOct 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748433 ↗MalfunctionOct 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748418 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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