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CORE 5400277000Recalls & reported problems

Stryker Corporation · Sterilization Case, Medium · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540427328), received between Feb 19, 2019 and Feb 19, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Cataract1
  • Retinal Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT THE DEVICE HANDLE APPARENTLY BROKE OFF WHEN THE USER TRIED TO PULL THE CASE OUT OF A CART. IT IS THE USER FACILITY POSITION THAT THE HANDLE HIT THE USER IN THE EYE AND CAUSED A RETINAL DETACHMENT FOR WHICH THE USER HAS HAD THREE SURGERIES AND HAS FURTHER DEVELOPED A CATARACT.

    Patient problems: Cataract; Retinal Injury

    MAUDE report 8351616 ↗

Other TRAY, SURGICAL, INSTRUMENT devices

All TRAY, SURGICAL, INSTRUMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.