T7Plus 0416-801-000Recalls & reported problems

Stryker Corporation · Hood with Standard Face Shield · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327465884), received between Oct 22, 2024 and Apr 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Contaminated During Manufacture or Shipping2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 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 21878602 ↗
MalfunctionOct 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 2 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20504487 ↗

Device details

UDI-DI	`07613327465884`
Brand	T7Plus
Model	0416-801-000
Company	Stryker Corporation
Product code	FXY · HOOD, SURGICAL
Class	Class 2
FDA submission	K200493
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 7, 2021

Device type (GMDN): Surgical gown, single-use

A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Other HOOD, SURGICAL devices

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9 reports
Flyte, SurgiCool 0408801500
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T7 0416-800-200
Stryker Corporation · HOOD, SURGICAL
5 reports
T7Plus 0416-801-100
Stryker Corporation · HOOD, SURGICAL
3 reports
T7Plus 0416-801-200
Stryker Corporation · HOOD, SURGICAL
3 reports
T7 0416-800-100
Stryker Corporation · HOOD, SURGICAL
2 reports

All HOOD, SURGICAL devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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