StrykeFlow 0250070500Recalls & reported problems
Stryker Corporation · 2, Disposable Suction/Irrigator without Disposable Tip · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker StrykeFlow suction and irrigation device is used in general and plastic surgery. The 285 reports often describe smoking and overheating, and packaging containing debris or foreign material. The reports include no deaths and 2 injuries. There are 2 recalls: one is open over possible fluid leaks into the handpiece and battery pack, and one is closed over contamination above the firm's internal limits. Reports fell to 15 in the last year from 142 the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 287
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 07613327061390), received between Jun 26, 2018 and Sep 9, 2026 — classified as 2 injuries, 285 malfunctions.
The most frequently reported specific device problem is “Smoking” (78 reports).
2 FDA recall records name this device's identifier, 1 still open.
1 other recall 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 18, 2025Open, Classified
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Z-2170-2025 · Root cause: Under Investigation by firm · FDA record ↗
- Nov 17, 2017Terminated
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Z-0835-2018 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Smoking78
- Temperature Problem48
- Overheating of Device46
- Device Contaminated During Manufacture or Shipping33
- Packaging Problem32
- Contamination /Decontamination Problem26
- Leak/Splash26
- Contamination16
Patient problems
- No Clinical Signs, Symptoms or Conditions229
- Insufficient Information46
- No Known Impact Or Consequence To Patient39
- Skin Irritation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burn(s)1
- Complaint, Ill-Defined1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696906 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245602 ↗MalfunctionAug 5, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150182 ↗MalfunctionAug 5, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150032 ↗MalfunctionJul 10, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25784117 ↗MalfunctionJun 18, 2026Electrical Shorting
IT WAS REPORTED THAT LEAKAGE FROM THE CONNECTION WITH THE SALINE PACK ENTERED THE BATTERY COMPARTMENT, RESULTING IN A SHORT CIRCUIT. THE DEVICE GENERATED HEAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552712 ↗MalfunctionApr 2, 2026Material Fragmentation
IT WAS REPORTED THAT THE TIP WAS DAMAGED. IT FELL INSIDE THE BODY BUT HAS BEEN RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769842 ↗MalfunctionJan 16, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099945 ↗MalfunctionJan 13, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEBRIS WAS FOUND INSIDE THE STERILE PACKAGE UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24056830 ↗MalfunctionDec 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT ONE UNIT WAS OBSERVED TO HAVE A BLUE FLECK ON THE INSIDE OF THE PACKAGING, AND THE OTHER UNIT HAD A BLUE SMEAR ON THE PART ITSELF, AS WELL AS A FLECK OF SOMETHING ON THE RED KNOB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23884396 ↗MalfunctionDec 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT ONE UNIT WAS OBSERVED TO HAVE A BLUE FLECK ON THE INSIDE OF THE PACKAGING, AND THE OTHER UNIT HAD A BLUE SMEAR ON THE PART ITSELF AS WELL AS A FLECK OF SOMETHING ON THE RED KNOB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23884364 ↗MalfunctionDec 23, 2025Sparking; Sparking
IT WAS REPORTED THAT A STRYKEFLOW WAS BEING USED IN A CASE ON A PATIENT AND IT STARTED MAKING A LOUD NOISE AND THEN SPARKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23883505 ↗MalfunctionDec 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE CUSTOMER FOUND DEBRIS INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762009 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE CUSTOMER OPENED THE PACKAGE AND SAW BLUE FUZZY SUBSTANCE IN THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659588 ↗MalfunctionNov 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS BLACK SMUDGE ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576308 ↗MalfunctionNov 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEBRIS WAS FOUND INSIDE THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550303 ↗MalfunctionNov 12, 2025Decrease in Pressure; Key or Button Unresponsive/not Working; Decrease in Pressure; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT WHILE USING THE DEVICE, THE RED SUCTION BUTTON REMAINED STUCK IN CONTINUOUS SUCTION MODE. THERE WERE NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23537247 ↗MalfunctionOct 21, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT AS SOON AS THE DEVICE WAS OPENED AND USED FOR THE FIRST TIME, CONTINUOUS SUCTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353119 ↗MalfunctionSep 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23139873 ↗MalfunctionJul 9, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE SUCTION IRRIGATOR BEGAN MAKING AN ODD NOISE DURING IRRIGATION AND OVERHEATED. THE STAFF HAVE STATED THE SUCTION IRRIGATOR APPEARED TO OVERHEAT TO THE POINT OF SMOKING. AS REPORTED, THE BATTERIES WERE SO HOT, THEY COULD NOT BE TOUCHED. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459845 ↗MalfunctionJul 9, 2025Leak/Splash; Overheating of Device; Smoking; Leak/Splash; Overheating of Device; Smoking
IT WAS REPORTED THAT THE SUCTION IRRIGATOR FOR WAS BEING USED FOR 15-30 MINUTES, THE TIP STARTED LEAKING. STAFF ATTEMPTED TO UNSTICK BUTTON, IN CASE THAT WAS CAUSING IT TO RUN AND DISPENSE SALINE OUTSIDE PATIENT, DID NOT FIX THE ISSUE. SURGEON OBSERVED THAT THE TIP WAS "SMOKING." AT THIS TIME, SUCTION IRRIGATOR WAS REMOVED FROM STERILE FIELD, REPLACED WITH NEW DEVICE. MOTOR FOR IRRIGATOR WAS STILL RUNNING AT THIS TIME, AS IF THE BUTTON WAS FULLY DEPRESSED, BATTERY COMPARTMENT/MOTOR WHERE IRRIGATOR SPIKES SALINE BAG HOT TO THE TOUCH. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22457387 ↗MalfunctionJul 2, 2025Overheating of Device; Smoking; Excessive Heating; Overheating of Device; Smoking; Excessive Heating
IT WAS REPORTED THAT THE STRYKEFLOW 2 BEGAN MAKING A NOISE DURING THE SURGICAL PROCEDURE, BEGAN OVERHEATING AND SMOKING WHILE BEING USED ON A PATIENT. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 22383470 ↗MalfunctionJul 2, 2025Overheating of Device; Smoking; Excessive Heating; Overheating of Device; Smoking; Excessive Heating
IT WAS REPORTED THAT THE STRYKEFLOW 2 BEGAN MAKING A NOISE DURING THE SURGICAL PROCEDURE, BEGAN OVERHEATING AND SMOKING WHILE BEING USED ON A PATIENT. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 22383467 ↗MalfunctionJul 2, 2025Overheating of Device; Smoking; Excessive Heating; Overheating of Device; Smoking; Excessive Heating
IT WAS REPORTED THAT THE STRYKEFLOW 2 BEGAN MAKING A NOISE DURING THE SURGICAL PROCEDURE, BEGAN OVERHEATING AND SMOKING WHILE BEING USED ON A PATIENT. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383132 ↗MalfunctionJul 2, 2025Overheating of Device; Smoking; Excessive Heating; Overheating of Device; Smoking; Excessive Heating
IT WAS REPORTED THAT THE STRYKEFLOW 2 BEGAN MAKING A NOISE DURING THE SURGICAL PROCEDURE, BEGAN OVERHEATING AND SMOKING WHILE BEING USED ON A PATIENT. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 22383130 ↗
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-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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.