T7Plus 0416-801-100Recalls & reported problems
Stryker Corporation · Hood with Peel Away Face Shield · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327465891), received between Jan 25, 2023 and Apr 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 Product2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 21878614 ↗MalfunctionOct 23, 2023Delivered 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 17986222 ↗MalfunctionJan 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE USER FACILITY REPORTED THAT THE DEVICE HAD A HAIR IN A STERILE T7 HOOD. IT CONTAMINATED THE ENTIRE ROOM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16239459 ↗
Other HOOD, SURGICAL devices
- Flyte, SurgiCool 0408801400Stryker Corporation · HOOD, SURGICAL9 reports
- Flyte, SurgiCool 0408801500Stryker Corporation · HOOD, SURGICAL7 reports
- T7 0416-800-200Stryker Corporation · HOOD, SURGICAL5 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.
How reports and recalls are matched · Editorial policy · Report an error on this page