AHTO 0250070620Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07613327061659), received between Jun 14, 2019 and Aug 31, 2026 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (18 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. 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-2863-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 17, 2017Class IITerminated

   Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

   Z-0836-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532314 ↗
• MalfunctionJul 27, 2026Material Fragmentation

  It was reported that during a procedure using a Stryker AHTO 250-070-620 irrigation/suction set connected to a B. Braun Ecobag 0.9% NaCl 3000 ml tubing, the scrub nurse noticed a piece of gray plastic in the cup after purging the system.No serious consequences for the patient.Please note, the NaCl irrigation solution bag is not a Stryker product. It was alleged that this issue occurred when using the Stryker AHTO tubeset.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000055 ↗
• MalfunctionJun 3, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN EMERGENCY SURGICAL PROCEDURE (LAPAROSCOPIC APPENDECTOMY), THE SURGICAL TEAM IDENTIFIED A LOOSE PIECE OF RUBBER IN THE ABDOMINAL CAVITY. THIS FRAGMENT ORIGINATED FROM A PUNCTURE IN THE STOPPER OF THE 0.9% NACL IRRIGATION SOLUTION BAG (REF (B)(4) AND BATCH 25493767) DURING CONNECTION TO THE STRYKER AHTO IRRIGATION TUBING (REF (B)(4), BATCH UNKNOWN). THE FRAGMENT WAS RETRIEVED. DURING THE PROCEDURE, WHEN A SECOND BAG OF THE SAME REFERENCE NUMBER WAS PUNCTURED, THE CORE SAMPLING PHENOMENON WAS OBSERVED ONCE AGAIN. THE FRAGMENT SPILLED OUT WITH THE NACL SOLUTION WHILST FILLING A CUP. NO SERIOUS CONSEQUENCES FOR THE PATIENT. PLEASE NOTE, THE NACL IRRIGATION SOLUTION BAG IS NOT A STRYKER PRODUCT. IT WAS ALLEGED THAT THIS ISSUE OCCURRED WHEN USING THE STRYKER AHTO TUBESET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383650 ↗
• MalfunctionJun 3, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN EMERGENCY SURGICAL PROCEDURE (LAPAROSCOPIC APPENDECTOMY), THE SURGICAL TEAM IDENTIFIED A LOOSE PIECE OF RUBBER IN THE ABDOMINAL CAVITY. THIS FRAGMENT ORIGINATED FROM A PUNCTURE IN THE STOPPER OF THE 0.9% NACL IRRIGATION SOLUTION BAG (REF (B)(4) AND BATCH 25493767) DURING CONNECTION TO THE STRYKER AHTO IRRIGATION TUBING (REF (B)(4), BATCH UNKNOWN). THE FRAGMENT WAS RETRIEVED. DURING THE PROCEDURE, WHEN A SECOND BAG OF THE SAME REFERENCE NUMBER WAS PUNCTURED, THE CORE SAMPLING PHENOMENON WAS OBSERVED ONCE AGAIN. THE FRAGMENT SPILLED OUT WITH THE NACL SOLUTION WHILST FILLING A CUP. NO SERIOUS CONSEQUENCES FOR THE PATIENT. PLEASE NOTE, THE NACL IRRIGATION SOLUTION BAG IS NOT A STRYKER PRODUCT. IT WAS ALLEGED THAT THIS ISSUE OCCURRED WHEN USING THE STRYKER AHTO TUBESET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383648 ↗
• MalfunctionFeb 9, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGE CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300023 ↗
• MalfunctionFeb 4, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A LONG BLACK HAIR WAS FOUND INSIDE THE PACKAGING..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260868 ↗
• MalfunctionFeb 3, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STRYKER SUCTION IRRIGATION DEVICE BROKE AT THE BASE OF THE SUCTION TIP. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252857 ↗
• MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGE WAS CONTAMINATED ON THE INSIDE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957579 ↗
• MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BLACK ITEM WAS FOUND IN THE AHTO TUBESET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660665 ↗
• MalfunctionNov 26, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE INFUSION WAS PUNCTURED, A PIECE OF RUBBER WAS PUNCHED OUT AND ENTERED THE INFUSION FLUID. THE INFUSION WHERE THE PIECE OF RUBBER WAS PUNCHED OUT IS A B. BRAUN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660120 ↗
• MalfunctionNov 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHILE PULLING PRODUCTS FOR CASE SETUP, THE DISPOSABLE SUCTION/IRRIGATOR TUBE SET WITH TIP WAS NOTED TO BE CONTAMINATED WITH MULTIPLE BLACK/BLUE/WHITE SPECKS IN BOTTOM OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577054 ↗
• MalfunctionNov 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING CASE SETUP, THE DISPOSABLE SUCTION/IRRIGATOR TUBE SET WITH TIP WAS NOTED TO BE CONTAMINATED WITH MULTIPLE BLACK/BLUE/WHITE SPECKS IN BOTTOM OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576002 ↗
• MalfunctionNov 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING CASE SETUP, THE DISPOSABLE SUCTION/IRRIGATOR TUBE SET WITH TIP WAS NOTED TO BE CONTAMINATED WITH MULTIPLE BLACK/BLUE/WHITE SPECKS IN BOTTOM OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575958 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak

  SUCTION IRRIGATOR WAS LEAKING IRRIGATION FLUID FROM HANDLE HUB SITE, EVEN WHEN NOT IN USE.NO IDENTIFIED HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424940 ↗
• MalfunctionOct 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR WAS DISCOVERED INSIDE THE PACKAGING AFTER OPENING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23382243 ↗
• MalfunctionOct 23, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE DEVICE HAD COMPROMISED PACKAGING. THEREFORE, THERE WAS BREACH IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374952 ↗
• MalfunctionOct 23, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE DEVICE HAD COMPROMISED PACKAGING. THEREFORE, THERE WAS BREACH IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374950 ↗
• MalfunctionOct 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR WAS DISCOVERED INSIDE THE PACKAGING AFTER OPENING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374522 ↗
• MalfunctionOct 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR WAS DISCOVERED INSIDE THE PACKAGING AFTER OPENING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374521 ↗
• MalfunctionOct 16, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PISTON TAKES A LONG TIME TO RETURN, RESULTING IN CONTINUOUS SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318906 ↗
• MalfunctionAug 20, 2025Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A SMALL RED PLASTIC PIECE WAS FOUND INSIDE OF THE PACKAGE. THERE WAS NO SIGNS OF DAMAGE FOUND ON THE SUCTION IRRIGATOR TUBE SET. UNSURE OF WHERE THE RED PLASTIC PIECE CAME FROM. DEEMED CONTAMINATED DUE TO UNKNOWN FOREIGN OBJECT ORIGIN. NEW PRODUCT WAS OBTAINED AND USED. PER OR MATERIALS MANAGEMENT: RED PIECE APPEARS TO BE BROKEN OFF FROM INTERNAL COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850258 ↗
• MalfunctionJul 9, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE LOSES WATER THROUGH THE BLUE BUTTON, AND THE RED ONE GETS STUCK AND STAYS OPEN WHILE VACUUMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461514 ↗
• MalfunctionJul 9, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE LOSES WATER THROUGH THE BLUE BUTTON, AND THE RED ONE GETS STUCK AND STAYS OPEN WHILE VACUUMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461510 ↗
• MalfunctionJul 9, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE LOSES WATER THROUGH THE BLUE BUTTON, AND THE RED ONE GETS STUCK AND STAYS OPEN WHILE VACUUMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461500 ↗
• MalfunctionJul 9, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE LOSES WATER THROUGH THE BLUE BUTTON, AND THE RED ONE GETS STUCK AND STAYS OPEN WHILE VACUUMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461499 ↗