Hydro-SurgRecalls & reported problems across all models
Davol Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Hydro-Surg model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 307
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 2
We found 8 models of Hydro-Surg by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 307 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and May 22, 2025 — classified as 3 injuries, 304 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (254 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
Hydro-Surg 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 7, 2022Open, Classified
The product is not able to provide irrigation.
Z-1305-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 7, 2022Open, Classified
The product is not able to provide irrigation.
Z-1304-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Hydro-Surg problems
Device problems
- Fluid/Blood Leak254
- Corroded107
- Detachment of Device or Device Component23
- Insufficient Device Problem Information9
- Device Contamination with Chemical or Other Material8
- Overheating of Device7
- Smoking7
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions259
- No Consequences Or Impact To Patient41
- No Patient Involvement3
- Burn(s)1
- Insufficient Information1
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Hydro-Surg models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hydro-Surg 0026870Laparoscope, general & plastic surgery1 recall209 reports
- Hydro-Surg 0026880Laparoscope, general & plastic surgery1 recall87 reports
- Hydro-Surg 5600160ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Hydro-Surg 5539700Laparoscope, general & plastic surgery2 reports
- Hydro-Surg 5600200ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Hydro-Surg 5600240ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Hydro-Surg 5600100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Hydro-Surg 5600180ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Hydro-Surg adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, THREE HYDRO-SURG PLUS IRRIGATORS (DEVICE #1 , #2 & #3) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069861 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069860 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, THREE HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2 & #3) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069844 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069843 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069842 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, THREE HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2 & #3) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069840 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, TWO HYDRO-SURG PLUS IRRIGATORS (DEVICE #1 & #2) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069838 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, TWO HYDRO-SURG PLUS IRRIGATORS (DEVICE #1 & #2) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069826 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069819 ↗MalfunctionJan 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING ROBOTIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025, HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR WAS LEAKED PREOPERATIVELY. IT WAS REPORTED THAT THE LEAKING WAS NOTED "AT CONNECTION" AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284594 ↗MalfunctionNov 22, 2024Break; Break
AS REPORTED, DURING A PROCEDURE, THE MALE (QD) ADAPTOR ON THE ND TRUMPET VALVE OF THE HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR BROKE OFF. IT WAS REPORTED THAT ALL PIECES WERE REMOVED, A NEW HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20763386 ↗MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A PROCEDURE, THE WHITE CAP (ND VALVE BODY PLUG) OF HYDRO-SURG PLUS IRRIGATOR POPPED OFF CAUSING THE HANDLE TO LEAK IRRIGATION FLUID. IT WAS REPORTED THAT THE OR STAFF TIGHTENED THE WHITE CAP PRIOR TO USE TO ENSURE IT WAS SECURED ONTO THE ND HANDLE. IT WAS ALSO REPORTED THAT ANOTHER IRRIGATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179705 ↗MalfunctionAug 1, 2024Break; Break
AS REPORTED, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE HYDRO-SURG IRRIGATOR BROKE AND MALFUNCTIONED DURING A CASE. IT WAS REPORTED THAT THE TWO DEVICES, THE PLASTIC AT THE END WHERE THE SUCTION TIP WAS CRACKED (MALE ADAPTER), MAKING IT IMPOSSIBLE TO GET THE PROPER SEAL AND SUCTION. THE SURGEON TRIED TURNING UP THE SUCTION FOR THE TWO THAT CRACKED BUT THE SUCTION TIP WOULD NOT STAY ATTACHED. IT WAS ALSO REPORTED THAT THE SURGEON USED ANOTHER NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19882753 ↗MalfunctionJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING LAPAROSCOPIC HEMICOLECTOMY PROCEDURE ON (B)(6) 2024, THE PLASTIC WHITE CAP OF HYDRO-SURG IRRIGATOR FELL ONTO THE FLOOR WHEN HOOKING UP AT START OF CASE AND BECAME UNSTERILE. IT WAS REPORTED THAT TUBING DID NOT WORK, AND SUCTION COULD NOT BE MAINTAINED, IT WAS UNKNOWN WHETHER THE WHITE CAP WAS CHECKED AND SECURED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER HYDROSURG DEVICE OF THE SAME LOT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646188 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046256 ↗
Other Davol Inc. products
All Davol Inc. devices →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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