StrykeFlowRecalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one StrykeFlow model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 552
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 4
We found 4 models of StrykeFlow by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 552 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Sep 29, 2026 — classified as 5 injuries, 547 malfunctions.
The most frequently reported specific device problem is “Smoking” (129 reports).
4 FDA recall records name at least one of these models by its device identifier, 3 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. 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
StrykeFlow recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 8, 2026Open, Classified
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Z-2865-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · 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 · names 3 of these models · Recall details · FDA record ↗
Most reported StrykeFlow problems
Device problems
- Smoking129
- Overheating of Device83
- Temperature Problem81
- Decrease in Pressure70
- Device Contaminated During Manufacture or Shipping61
- Packaging Problem50
- Leak/Splash44
- Contamination /Decontamination Problem43
Patient problems
- No Clinical Signs, Symptoms or Conditions450
- Insufficient Information84
- No Known Impact Or Consequence To Patient62
- Hemorrhage/Blood Loss/Bleeding3
- Skin Irritation3
- Chemical Exposure2
- No Consequences Or Impact To Patient2
- No Information2
StrykeFlow models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- StrykeFlow 0250070500Laparoscope, general & plastic surgery2 recalls287 reports
- StrykeFlow 0250070520APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 recalls250 reports
- StrykeFlow 0250070530ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall12 reports
- StrykeFlow 0250070505APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall3 reports
Recent StrykeFlow adverse event reports
The 15 most recent reports across all models, 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 50696906 ↗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 ↗
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
- 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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