AHTO 0250070600Recalls & reported problems
Stryker Corporation · Disposable Suction/Irrigator Tube Set · Class 2
All models of AHTO (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker disposable suction/irrigator tube set is used to draw fluid during gastro-urology procedures. The 44 reports mostly describe contamination found when the package was opened — black specks, a hair, white flakes — along with parts falling apart and leaking, which slows suction. No deaths and no injuries were reported, and all 44 were malfunctions. There is 1 open recall, started in June 2026 over leaking from the handpiece, and 1 closed recall from 2017 for higher-than-acceptable bioburden in certain lots.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07613327061499), received between Sep 10, 2018 and Jun 29, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (11 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 16, 2026.
Reports received per month
Recalls naming this device
- Jun 8, 2026Open, Classified
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Z-2862-2026 · 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-0836-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping11
- Decrease in Pressure10
- Mechanical Problem8
- Obstruction of Flow7
- Pressure Problem7
- Contamination /Decontamination Problem4
- Packaging Problem4
- Suction Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Known Impact Or Consequence To Patient11
- Insufficient Information9
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Device Contaminated at the User Facility
IT WAS REPORTED THAT THE TUBESET WAS CONTAMINATED (BLACK SPEC) UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660877 ↗MalfunctionDec 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23883929 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT BLACK SPECKS WERE DISCOVERED INSIDE THE PACKAGING OF THE SUCTION IRRIGATORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660689 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT BLACK SPECKS WERE DISCOVERED INSIDE THE PACKAGING OF THE SUCTION IRRIGATORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660213 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT BLACK SPECKS WERE DISCOVERED INSIDE THE PACKAGING OF THE SUCTION IRRIGATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660207 ↗MalfunctionNov 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE SCRUB TECH FOUND WHITE FLAKES ON THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23612171 ↗MalfunctionOct 23, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE LEAKED AND WAS NOT SECURE AND FALLING APART. THE STAFF HAD TO DEAL WITH A LOSS IN PRESSURE AND THEREFORE SLOWER SUCTION RATE OF FLUID OUT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375168 ↗MalfunctionOct 23, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE LEAKED AND WAS NOT SECURE AND FALLING APART. THE STAFF HAD TO DEAL WITH A LOSS IN PRESSURE AND THEREFORE SLOWER SUCTION RATE OF FLUID OUT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375167 ↗MalfunctionOct 23, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE LEAKED AND WAS NOT SECURE AND FALLING APART. THE STAFF HAD TO DEAL WITH A LOSS IN PRESSURE AND THEREFORE SLOWER SUCTION RATE OF FLUID OUT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373952 ↗MalfunctionOct 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PACKAGING HAD BLACK SPECS IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23318722 ↗MalfunctionOct 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PACKAGING HAD BLACK SPECS IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23306094 ↗MalfunctionAug 13, 2025Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE CUSTOMER FOUND A HAIR IN THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22798794 ↗MalfunctionMay 9, 2025Decrease in Pressure; Mechanical Jam; Pressure Problem; Decrease in Pressure; Mechanical Jam; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997824 ↗MalfunctionMay 9, 2025Mechanical Problem; Decrease in Pressure; Pressure Problem; Mechanical Problem; Decrease in Pressure; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997723 ↗MalfunctionMay 9, 2025Mechanical Problem; Decrease in Pressure; Pressure Problem; Mechanical Problem; Decrease in Pressure; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996813 ↗MalfunctionMay 9, 2025Mechanical Problem; Decrease in Pressure; Pressure Problem; Mechanical Problem; Decrease in Pressure; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996631 ↗MalfunctionMay 9, 2025Mechanical Problem; Decrease in Pressure; Pressure Problem; Mechanical Problem; Decrease in Pressure; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996630 ↗MalfunctionMay 9, 2025Mechanical Problem; Decrease in Pressure; Pressure Problem; Mechanical Problem; Decrease in Pressure; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996571 ↗MalfunctionMay 9, 2025Mechanical Problem; Decrease in Pressure; Pressure Problem; Mechanical Problem; Decrease in Pressure; Pressure Problem
IT WAS REPORTED THAT THE RED BUTTON WAS STICKING, PULLING PNEUMO, POTENTIALLY EFFECTING PATIENT SAFETY. THEREFORE, THERE WAS LOSS OF INSUFFLATION. THE DELAY FOR THE CASE WAS LONGER THAN 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996086 ↗MalfunctionMar 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21532905 ↗MalfunctionJan 4, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449381 ↗MalfunctionOct 12, 2023Device 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 17926210 ↗MalfunctionSep 2, 2021Complete Blockage; Suction Problem; Suction Problem
IT WAS REPORTED THAT THE DEVICE CLOGGED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12418777 ↗MalfunctionJul 8, 2021Suction Problem; Obstruction of Flow; Suction Problem
IT WAS REPORTED THAT THERE WAS CLOGGING DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12137326 ↗MalfunctionJul 8, 2021Obstruction of Flow; Suction Failure; Suction Failure
IT WAS REPORTED THAT THERE WAS CLOGGING DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12137321 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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