StrykeFlow 0250070505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327061406), received between Jun 23, 2022 and Jun 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

1 FDA recall record name this device's identifier.

21 other recalls cover devices cleared under the same FDA submission (K954726); 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.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE UNIT HAVE BEEN GETTING EXTREMELY HOT AND LEAKING DURING PROCEDURE. THEREFORE THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205825 ↗
• MalfunctionJun 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE UNIT HAVE BEEN GETTING EXTREMELY HOT AND LEAKING DURING PROCEDURE. THEREFORE, THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205730 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS ALLEGED THAT A PIECE OF THE PRODUCT BROKE AND WENT INSIDE THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791032 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954726. One submission often covers many models, so check the product and lot details in each record.

• Z-2171-2025 · Jun 18, 2025 · Open, Classified
  Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
• Z-1225-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
• Z-1228-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic sur
• Z-1218-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery
• Z-1231-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopi
• Z-1234-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative sit
• Z-1220-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
• Z-1233-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic
• Z-1223-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic sur
• Z-1235-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparo
• Z-1237-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surg
• Z-1230-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic
• Z-1229-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic
• Z-1226-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surg
• Z-1221-2013 · Mar 27, 2013 · Terminated
  Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surg

…and 6 more.