StrykeFlow 0250070530Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327061352), received between Oct 26, 2018 and Aug 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K963646); 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.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO OPENING STERILE SUPPLIES FOR AN OR CASE, A PIECE OF WHAT LOOKS LIKE HAIR WAS FOUND INSIDE THE PACKAGE OF A DISPOSABLE ITEM. THE ITEM WAS NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868654 ↗
• MalfunctionJun 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A FOREIGN OBJECT PRESENT UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205978 ↗
• MalfunctionJun 5, 2025Mechanical Problem; Decrease in Pressure; Mechanical Problem; Decrease in Pressure

  IT WAS REPORTED BY THE CUSTOMER THAT THE RED BUTTON WAS NOT WORKING PROPERLY ON THE TUBING. THEREFORE THERE WAS A LOSS OF INSUFFLATION.

  Patient problems: Insufficient Information

  MAUDE report 22149440 ↗
• MalfunctionJun 3, 2025Nonstandard Device; Device Contaminated During Manufacture or Shipping; Nonstandard Device; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A FOREIGN OBJECT FOUND IN THE STERILIZED PACK PRIOR TO OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137073 ↗
• MalfunctionMar 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642203 ↗
• MalfunctionJan 14, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153831 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. PLEASE NOTE THE DEVICE BROKE OUTSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357461 ↗
• MalfunctionMar 31, 2020Material Discolored; Delivered as Unsterile Product; Contamination /Decontamination Problem; Material Discolored

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904121 ↗
• MalfunctionMar 12, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATERIALS WERE FOUND INSIDE THE STERILE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9823453 ↗
• MalfunctionJan 21, 2020Contamination; Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT FOREIGN MATERIALS WERE FOUND INSIDE THE STERILE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611766 ↗
• MalfunctionDec 21, 2018Fluid/Blood Leak

  THE STRYKER STRYKEFLOW DISPOSABLE SUCTION/IRRIGATOR SINGLE SPIKE TUBING WAS LEAKING FLUID ONTO THE FIELD. THIS IS ONE OF MANY EVENTS IN WHICH THIS PRODUCT HAS BEEN LEAKING. THIS EVENT WAS THE FIRST TIME IN WHICH THE TUBING WAS SAVED TO BE RETURNED FOR INVESTIGATION, THEREFORE, A REPORT WAS FILED. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, STRYKEFLOW (PER SITE REPORTER). THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. ANY CORRESPONDENCE WILL BE SHARED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188934 ↗
• MalfunctionOct 26, 2018Leak/Splash

  WHILE DOING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SURGEON WAS USING THE STRYKER STRYKEFLOW SUCTION IRRIGATION TUBING. DURING THE CASE, SALINE BEGAN TO LEAK FROM THE HAND PIECE CAUSING FLUID TO FLOW ONTO THE PATIENT AND THE SURGEON. THE DEVICE WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED AS PLANNED. NO HARM CAME TO THE PATIENT. SEVERAL SIMILAR OCCURRENCES HAVE BEEN REPORTED FROM THE OR SURGICAL STAFF, HOWEVER, NO SAMPLES HAVE BEEN SAVED POST-OPERATIVELY. IF A FUTURE SAMPLE IS SAVED, IT WILL BE RETURNED TO THE MANUFACTURER.

  Patient problems: Chemical Exposure

  MAUDE report 8008726 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963646. One submission often covers many models, so check the product and lot details in each record.

• Z-2866-2026 · Jun 8, 2026 · Open, Classified
  STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540