CORERecalls & reported problems across all models

We found 21 models of CORE by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 469 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Nov 12, 2025 — classified as 3 injuries, 466 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (286 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

Most reported CORE problems

CORE models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CORE 5400034000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  87 reports
• CORE 5400015000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  74 reports
• CORE 5400050000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  73 reports
• CORE 5400120000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  45 reports
• CORE 5400100000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  29 reports
• CORE 5400110000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  26 reports
• CORE 5400052000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  25 reports
• CORE 5400037000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  22 reports
• CORE 5400031000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  21 reports
• CORE 5400099000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  20 reports
• CORE 5400010058

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  12 reports
• CORE 5400300000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  8 reports
• CORE 5402007000

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  7 reports
• CORE 5400111000

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  4 reports
• CORE 5400050001

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  4 reports
• CORE 5400210000

  MOTOR, DRILL, PNEUMATIC
  4 reports
• CORE 5400010059

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  2 reports
• CORE 5400010258

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  2 reports
• CORE 5400120000S1

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  2 reports
• CORE 5400277000

  TRAY, SURGICAL, INSTRUMENT
  1 report
• CORE 5400210150

  MOTOR, DRILL, PNEUMATIC
  1 report

Recent CORE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Overheating of Device; Overheating of Device

  NO UPDATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532820 ↗
• InjuryJun 26, 2025Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRAUMA ADD-ON CASE FROM THE EMERGENCY ROOM, THE CONSOLE WOULD NOT WORK. THE USER FACILITY DID NOT HAVE BACKUP EQUIPMENT. THE TRAUMA PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY AFTER THE PATIENT WAS TRANSFERRED TO A SISTER FACILITY. NO ADDITIONAL MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED. IT IS REPORTED THAT THE PATIENT IS DOING FINE. THIS REPORT IS BEING SUBMITTED DUE TO THE NEED TO TRANSFER THE PATIENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336526 ↗
• MalfunctionJun 4, 2025Overheating of Device; Overheating of Device

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143796 ↗
• MalfunctionApr 11, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED RUN ON DURING A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826184 ↗
• MalfunctionApr 11, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED RUN ON DURING A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825892 ↗
• MalfunctionMar 18, 2025Overheating of Device; Overheating of Device

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634935 ↗
• MalfunctionJan 23, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217586 ↗
• MalfunctionJan 23, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217450 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 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 21200286 ↗
• MalfunctionDec 19, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A CASE AT THE USER FACILITY, THE CONSOLE HAD UNINTENDED ACTIVATION. 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 20976537 ↗
• MalfunctionOct 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HOT DURING A CASE AT THE USER FACILITY. 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 20532143 ↗
• MalfunctionOct 25, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532124 ↗
• MalfunctionOct 24, 2024Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529509 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500551 ↗
• MalfunctionSep 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE DISASSEMBLED DURING A PROCEDURE AT THE USER FACILITY. 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 20339884 ↗

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