StrykeFlow 0250070520Recalls & reported problems
Stryker Corporation · 2, Disposable Suction/Irrigator with Disposable Tip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker StrykeFlow disposable suction irrigator has 223 adverse event reports: 220 describe malfunctions and 3 describe injuries, with no deaths. Many reports describe the device smoking or overheating. Reports fell from 114 in the prior year to 37 in the latest year. There are 2 recalls, 1 open, one over irrigation fluid that may leak into the handpiece and battery, and one over germ levels in some lots.
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
- 250
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 07613327061369), received between Feb 12, 2019 and Sep 29, 2026 — classified as 3 injuries, 247 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (56 reports).
2 FDA recall records name this device's identifier, 1 still open.
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-2171-2025 · 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
- Decrease in Pressure56
- Smoking51
- Overheating of Device35
- Temperature Problem33
- Device Contaminated During Manufacture or Shipping23
- Packaging Problem18
- Leak/Splash17
- Contamination /Decontamination Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions212
- Insufficient Information37
- No Known Impact Or Consequence To Patient19
- Hemorrhage/Blood Loss/Bleeding3
- Anemia1
- Chemical Exposure1
- Deposits1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 250 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50940818 ↗MalfunctionSep 15, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50781550 ↗MalfunctionSep 10, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50725019 ↗MalfunctionSep 10, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50722466 ↗MalfunctionSep 10, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50716481 ↗MalfunctionSep 10, 2026Decrease in Pressure; Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707841 ↗MalfunctionSep 10, 2026Decrease in Pressure
It was reported that the buttons are sticking. The procedure was a laparoscopic cholecystectomy for cholecystitis. Per the report, "The suction has a lag time of activation and also continues to suction after the intended time". Loss of insufflation was confirmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707403 ↗MalfunctionSep 10, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50707401 ↗MalfunctionSep 10, 2026Decrease in Pressure
Patient problems: Insufficient Information
MAUDE report 50707225 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696915 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696521 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696520 ↗MalfunctionSep 9, 2026Decrease in Pressure
It was reported that It has been reported that the DISPOSABLE SUCTION IRRIGATIOR was Faulty. Button delay in suction activating and deactivating device, Suction button slows to react both on activation and deactivation creating a delay in suctioning out fluid from cavity and delay in ceasing suction creating danger in holding onto tissue, Suction very slow, red button doesn¿t fully suck. Loss of insufflation was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696518 ↗MalfunctionSep 9, 2026Decrease in Pressure
It was reported that It has been reported that the DISPOSABLE SUCTION IRRIGATIOR was Faulty. Button delay in suction activating and deactivating device, Suction button slows to react both on activation and deactivation creating a delay in suctioning out fluid from cavity and delay in ceasing suction creating danger in holding onto tissue, Suction very slow, red button doesn¿t fully suck. Loss of insufflation was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696517 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696516 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696190 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696184 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696182 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696177 ↗MalfunctionSep 9, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696173 ↗MalfunctionSep 9, 2026Decrease in Pressure
It was reported that It has been reported that the DISPOSABLE SUCTION IRRIGATIOR was Faulty. Button delay in suction activating and deactivating device, Suction button slows to react both on activation and deactivation creating a delay in suctioning out fluid from cavity and delay in ceasing suction creating danger in holding onto tissue, Suction very slow, red button doesn¿t fully suck. Loss of insufflation was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681810 ↗MalfunctionAug 28, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506046 ↗MalfunctionAug 28, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506045 ↗MalfunctionAug 28, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503523 ↗MalfunctionAug 28, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503277 ↗
Other APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED devices
- StrykeFlow 0250070505Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall3 reports
- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571315Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- CRD 65651-510Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571489Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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