NA 0250040113Recalls & reported problems
Stryker Corporation · Monopolar Electrosurgical Probe, J-Tip · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327061291), received between Dec 21, 2023 and Jan 17, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Arcing” (4 reports).
3 other recalls cover devices cleared under the same FDA submission (K934094); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Arcing4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2024Arcing; Arcing
IT WAS REPORTED THAT THERE WAS DAMAGED AND COMPROMISED INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531184 ↗MalfunctionJan 17, 2024Arcing; Arcing
IT WAS REPORTED THAT THERE WAS DAMAGED AND COMPROMISED INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531183 ↗MalfunctionJan 17, 2024Arcing; Arcing
IT WAS REPORTED THAT THERE WAS DAMAGED AND COMPROMISED INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531179 ↗MalfunctionDec 21, 2023Arcing; Arcing
IT WAS REPORTED THAT THE DEVICE ARCED AND CAUSED A MINOR BURN TO THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18378856 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K934094. One submission often covers many models, so check the product and lot details in each record.
- Z-2170-2025 · Jun 18, 2025 · Open, ClassifiedStryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Z-1509-2020 · Sep 12, 2019 · TerminatedStryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the followin
- Z-0835-2018 · Nov 17, 2017 · TerminatedStrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION
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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 14, 2026 · each report above links to its original FDA record
- 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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