RemBRecalls & reported problems across all models
Stryker Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,073
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 7 models of RemB by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 3,073 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Jan 15, 2026 — classified as 3 injuries, 3,070 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (1,837 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
Reports received per month, all models
Most reported RemB problems
Device problems
- Overheating of Device1,837
- Device Remains Activated631
- Fluid/Blood Leak180
- Detachment of Device or Device Component165
- Unintended Power Up161
- Fracture40
- Fail-Safe Did Not Operate31
- Fail-Safe Problem24
Patient problems
- No Clinical Signs, Symptoms or Conditions1,768
- No Patient Involvement1,103
- No Consequences Or Impact To Patient263
- No Known Impact Or Consequence To Patient49
- Burn(s)26
- Insufficient Information21
- No Information6
- Partial thickness (Second Degree) Burn3
RemB models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RemB 6400034000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- RemB 6400015000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- RemB 6400031000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE378 reports
- RemB 6400037000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE270 reports
- RemB 6400099000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE118 reports
- RemB 6400062000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE73 reports
- RemB 6400009000DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE13 reports
Recent RemB adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Overheating of Device
IT WAS REPORTED THE DEVICE OVERHEATED. FURTHER INFORMATION REGARDING PATIENT INVOLVEMENT WAS NOT PROVIDED BUT THE CUSTOMER; HOWEVER, NO ADVERSE CONSEQUENCES WERE ALLEGED.
Patient problems: Insufficient Information
MAUDE report 24081742 ↗MalfunctionDec 23, 2025Overheating of Device; Overheating of Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878381 ↗MalfunctionOct 22, 2025Overheating of Device; Overheating of Device
IT WAS 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 23360792 ↗MalfunctionOct 22, 2025Overheating of Device; Overheating of Device
IT WAS 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 23358860 ↗MalfunctionOct 17, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT THE DEVICE METAL SHAVINGS FELL OUT OF THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324164 ↗MalfunctionOct 17, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323539 ↗MalfunctionOct 17, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322642 ↗MalfunctionOct 15, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299649 ↗MalfunctionSep 4, 2025Overheating of Device; Overheating of Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963062 ↗MalfunctionSep 4, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THERE WAS CLINICALLY INSIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962878 ↗MalfunctionAug 20, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850814 ↗MalfunctionJul 21, 2025Overheating of Device; Overheating of Device
THE DEVICE OVERHEATED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22557608 ↗MalfunctionJul 11, 2025Overheating of Device; Overheating of Device
IT WAS 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 22481806 ↗MalfunctionJul 11, 2025Overheating of Device; Overheating of Device
IT WAS 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 22481064 ↗MalfunctionJul 11, 2025Overheating of Device; Overheating of Device
IT WAS 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 22480878 ↗
Other Stryker Corporation products
- 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
- InTouch5 models · 666 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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