Flyte 0408840100Recalls & reported problems
Stryker Corporation · Peel-Away Toga, 2X Large · Class 2
Data updated Oct 13, 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 04546540591852), received between Apr 24, 2019 and Apr 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
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 21878613 ↗MalfunctionApr 24, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8545997 ↗
Other GOWN, SURGICAL devices
- Medline DYNJP2001SMedline Industries, Inc. · GOWN, SURGICAL2 recalls9 reports
- Medline DYNJP2202SMedline Industries, Inc. · GOWN, SURGICAL2 recalls5 reports
- MEDLINE DYNJP2002SMedline Industries, Inc. · GOWN, SURGICAL2 recalls4 reports
- Medline DYNJP2602Medline Industries, Inc. · GOWN, SURGICAL2 recalls3 reports
- Medline Industries, Inc. DYNJP2402Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- MEDLINE DYNJP2002Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline DYNJP2103Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2203Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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