AHTO 0250070640Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327061475), received between Apr 11, 2019 and Mar 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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

4 other recalls cover devices cleared under the same FDA submission (K042454); 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 18, 2026.

Recalls naming this device

1. Jun 8, 2026Class IIOpen, Classified

   There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

   Z-2864-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664390 ↗
• MalfunctionApr 11, 2019Contamination /Decontamination Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506012 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042454. One submission often covers many models, so check the product and lot details in each record.

• Z-2862-2026 · Jun 8, 2026 · Open, Classified
  STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
• Z-2863-2026 · Jun 8, 2026 · Open, Classified
  STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
• Z-0836-2018 · Nov 17, 2017 · Terminated
  STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packagi
• Z-0279-06 · Nov 18, 2005 · Terminated
  StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endos