AHTORecalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one AHTO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 4
We found 4 models of AHTO by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Jun 25, 2018 and Aug 31, 2026 — classified as 1 injury, 109 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (30 reports).
4 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AHTO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 8, 2026Open, 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 ↗
- Jun 8, 2026Open, 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 ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported AHTO problems
Device problems
- Device Contaminated During Manufacture or Shipping30
- Decrease in Pressure18
- Mechanical Problem14
- Material Fragmentation11
- Contamination /Decontamination Problem10
- Leak/Splash8
- Material Puncture/Hole8
- Obstruction of Flow7
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- No Known Impact Or Consequence To Patient24
- Insufficient Information16
- Foreign Body In Patient4
- Burn, Thermal1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
AHTO models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AHTO 0250070620LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)2 recalls59 reports
- AHTO 0250070600EVACUATOR, GASTRO-UROLOGY2 recalls44 reports
- AHTO 0250070640LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall2 reports
- AHTO 0250070601APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED5 reports
Recent AHTO adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗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 ↗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 ↗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 ITEM WAS FOUND IN THE AHTO TUBESET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660665 ↗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 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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