StrykeprobeRecalls & reported problems across all models
Stryker Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 6 models of Strykeprobe by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2018 and Jun 12, 2026 — classified as 11 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Melted” (22 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 Strykeprobe problems
Device problems
- Melted22
- Arcing16
- Break9
- Temperature Problem8
- Thermal Decomposition of Device8
- Adverse Event Without Identified Device or Use Problem7
- Material Fragmentation5
- Overheating of Device5
Patient problems
- No Known Impact Or Consequence To Patient32
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information8
- Burn(s)7
- Burn, Thermal5
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
- Injury1
Strykeprobe models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Strykeprobe 0250070460ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES35 reports
- Strykeprobe 0250070443Laparoscope, general & plastic surgery28 reports
- Strykeprobe 0250070441Laparoscope, general & plastic surgery7 reports
- Strykeprobe 0250070442Laparoscope, general & plastic surgery3 reports
- Strykeprobe 0250070450Laparoscope, general & plastic surgery1 report
- Strykeprobe 0250070453ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Strykeprobe adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Overheating of Device; Temperature Problem
It was reported that the outer sheaths that look like it had some arcing and looked burnt during the case. They were looking at the L hooks, and it seems like the yellow insulation does not go all the way up to the hub. This happened during a case but no patient harm happened.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487283 ↗MalfunctionSep 30, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT WHILE THE DEVICE WAS BEING PULLED OUT OF THE PATIENT INTO THE SHEATH, IT BURNT THE SHEATH. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 23187042 ↗MalfunctionJun 10, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE OUTER PLASTIC SHEATH BROKE INSIDE THE PATIENT'S ABDOMEN DURING SURGERY. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176144 ↗MalfunctionApr 23, 2025Sparking; Sparking
IT WAS REPORTED THAT THE DEVICE SPARKED.
Patient problems: Insufficient Information
MAUDE report 21890716 ↗MalfunctionNov 15, 2024Arcing; Temperature Problem; Arcing; Temperature Problem
IT WAS REPORTED THERE DAMAGED/COMPROMISED INSULATION AND ARCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696060 ↗MalfunctionNov 15, 2024Arcing; Temperature Problem; Arcing; Temperature Problem
IT WAS REPORTED THERE DAMAGED/COMPROMISED INSULATION AND ARCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696054 ↗MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING HYSTEROSCOPY PROCEDURE THERE WAS DAMAGED/COMPROMISED INSULATION WHICH RESULTED IN PATIENT BURN. THE BURN OCCURRED IN THE UTERUS, WHICH WAS REMOVED AS PART OF THE HYSTEROSCOPY PROCEDURE, AND THEREFORE DID NOT RESULT IN PERMANENT IMPAIRMENT, IS NOT LIFE THREATENING, OR NECESSITATE UNPLANNED MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667822 ↗MalfunctionJul 3, 2024Arcing; Arcing
IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION WHICH RESULTED IN PATIENT BURN. THE BURN OCCURRED IN THE UTERUS, WHICH WAS REMOVED AS PART OF THE HYSTEROSCOPY PROCEDURE, AND THEREFORE DID NOT RESULT IN PERMANENT IMPAIRMENT, IS NOT LIFE THREATENING, OR NECESSITATE UNPLANNED MEDICAL INTERVENTION.
Patient problems: Burn(s)
MAUDE report 19667812 ↗MalfunctionJun 17, 2024Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem
IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19553570 ↗MalfunctionJun 17, 2024Material Fragmentation; Temperature Problem; Material Fragmentation; Temperature Problem
IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19553478 ↗MalfunctionJun 7, 2024Thermal Decomposition of Device; Temperature Problem; Thermal Decomposition of Device; Temperature Problem
IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488335 ↗InjuryMay 23, 2024Arcing; Material Too Soft/Flexible; Arcing; Material Too Soft/Flexible
IT WAS REPORTED THAT THE DEVICE ARCHED AND BURNED THE PATIENT REQUIRING A SUTURE REPAIR.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 19387688 ↗InjuryMay 23, 2024Arcing; Material Too Soft/Flexible; Arcing; Material Too Soft/Flexible
IT WAS REPORTED THE DEVICE ARCHED AND BURNED THE PATIENT REQUIRING A SUTURE TO REPAIR.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 19384109 ↗MalfunctionMay 13, 2024Melted; Melted
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT DUE TO DEVICE CATCHING ON FIRE. NO PATIENT HARM NO ADVERSE CONSEQUENCES NO MEDICAL INTERVENTION. THE PROBE DID NOT CATCH FIRE IN A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299206 ↗MalfunctionMay 13, 2024Melted; Melted
IT WAS REPORTED THAT THE DEVICE CAUGHT FIRE. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES. THE DEVICE DID NOT CATCH FIRE INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299059 ↗
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
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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