Surgiphor 910110Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00382909101102), received between Mar 2, 2023 and Aug 5, 2026 — classified as 140 malfunctions.

The most frequently reported specific device problem is “Crack” (131 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150356 ↗
• MalfunctionAug 5, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150355 ↗
• MalfunctionAug 5, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150044 ↗
• MalfunctionAug 5, 2026Crack

  As reported, during a orthopedic procedure Surgiphor bottle was cracked. The bottles were handed off successfully to the field without damage, but when the surgeon tried to use the product the bottle broke. Reportedly, "the bottles were very brittle and basically broke while being used." It was also reported that the product was stored at room temperature in the core prior to use and the cracked bottle fragments were contained and discarded. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150043 ↗
• MalfunctionJun 18, 2026Crack

  AS REPORTED, MULTIPLE SURGIPHOR BOTTLES HAD BUSTED IN DIFFERENT SPECIALTIES INCLUDING PLASTICS AND SPINE. IN PLASTICS THE BOTTLE WAS LEAKING AFTER SETTING IT IN ON THE TABLE. IN SPINE MULTIPLE BOTTLES HAVE BUSTED IN THE HANDS OF THE SURGEONS WHILE USING IT AS A MANUAL LAVAGE. REPORTEDLY, MAJORITY OF THE BOTTLES ARE BUSTING DURING USE WITH THE CAP STILL INTACT. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555239 ↗
• MalfunctionJun 18, 2026Crack

  AS REPORTED, MULTIPLE SURGIPHOR BOTTLES HAD BUSTED IN DIFFERENT SPECIALTIES INCLUDING PLASTICS AND SPINE. IN PLASTICS THE BOTTLE WAS LEAKING AFTER SETTING IT IN ON THE TABLE. IN SPINE MULTIPLE BOTTLES HAVE BUSTED IN THE HANDS OF THE SURGEONS WHILE USING IT AS A MANUAL LAVAGE. REPORTEDLY, MAJORITY OF THE BOTTLES ARE BUSTING DURING USE WITH THE CAP STILL INTACT. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555238 ↗
• MalfunctionJun 18, 2026Crack

  AS REPORTED, MULTIPLE SURGIPHOR BOTTLES HAD BUSTED IN DIFFERENT SPECIALTIES INCLUDING PLASTICS AND SPINE. IN PLASTICS THE BOTTLE WAS LEAKING AFTER SETTING IT IN ON THE TABLE. IN SPINE MULTIPLE BOTTLES HAVE BUSTED IN THE HANDS OF THE SURGEONS WHILE USING IT AS A MANUAL LAVAGE. REPORTEDLY, MAJORITY OF THE BOTTLES ARE BUSTING DURING USE WITH THE CAP STILL INTACT. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555236 ↗
• MalfunctionMay 13, 2026Crack

  AS REPORTED, DURING A PODIATRY PROCEDURE THE SURGIPHOR BOTTLE CRACKED WHILE IT WAS BEING SQUEEZED TO RELEASE THE SOLUTION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164829 ↗
• MalfunctionMay 12, 2026Crack

  AS REPORTED, THE BODY OF THE BOTTLE CRACKED AS THE SURGEON WAS SQUEEZING THE BOTTLE TO STREAM THE SOLUTION ONTO THE OPEN INCISION. THERE WAS NO INJURIES OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149594 ↗
• MalfunctionMay 12, 2026Crack

  AS REPORTED, THE BODY OF THE BOTTLE CRACKED AS THE SURGEON WAS SQUEEZING THE BOTTLE TO STREAM THE SOLUTION ONTO THE OPEN INCISION. THERE WAS NO INJURIES OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149587 ↗
• MalfunctionMay 12, 2026Crack

  AS REPORTED, THE BODY OF THE BOTTLE CRACKED AS THE SURGEON WAS SQUEEZING THE BOTTLE TO STREAM THE SOLUTION ONTO THE OPEN INCISION. THERE WAS NO INJURIES OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149579 ↗
• MalfunctionApr 1, 2026Crack

  AS REPORTED, THE SURGIPHOR BOTTLE BROKE IN THE HAND OF THE SURGEON DURING MANUAL LAVAGE AT RIGHT SHOULDER REPLACEMENT PROCEDURE. BOTTLE WAS DISPOSED OF, WOUND WAS CLEANED, DAMAGED PIECES WERE REMOVED AND OPERATION CONTINUED. THERE WAS NO PATIENT/USER INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757182 ↗
• MalfunctionMar 4, 2026Crack

  AS REPORTED, IT IS ALLEGED THAT THE TWO SURGIPHOR BOTTLES (DEVICE 1 AND 2) CRACKED DURING USE. IT WAS ALSO REPORTED THAT THE REPRESENTATIVE PRESENT WITH THE SURGEON INDICATED THAT THE BOTTLES MAY HAVE BEEN OPENED INCORRECTLY, WHICH REQUIRED HIM TO APPLY EXCESSIVE SQUEEZING. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512098 ↗
• MalfunctionMar 4, 2026Crack

  AS REPORTED, IT IS ALLEGED THAT THE TWO SURGIPHOR BOTTLES (DEVICE 1 AND 2) CRACKED DURING USE. IT WAS ALSO REPORTED THAT THE REPRESENTATIVE PRESENT WITH THE SURGEON INDICATED THAT THE BOTTLES MAY HAVE BEEN OPENED INCORRECTLY, WHICH REQUIRED HIM TO APPLY EXCESSIVE SQUEEZING. THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512096 ↗
• MalfunctionFeb 18, 2026Crack

  AS REPORTED, IT IS ALLEGED THAT THE SURGEON'S THUMB WENT THROUGH THE BOTTLE WHEN ATTEMPT TO USE. CUSTOMER WAS NOT SURE HOW THIS HAPPENED WHETHER SURGEON WAS APPLYING TO MUCH FORCE IS A POSSIBILITY OR MAYBE THE CAP WASN'T PUNCTURED CORRECTLY WHEN PREPARING. THERE WAS NO HARM TO SURGEON OR PATIENT. ALL PLASTIC PIECES WERE THERE ACCOUNTED FOR AND THERE WAS NO BREAK IN STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378811 ↗
• MalfunctionFeb 16, 2026Crack

  AS REPORTED, DURING A TOTAL KNEE REPLACEMENT, THE SURGEON WENT TO SQUEEZE THE SURGIPHOR BOTTLE AS DIRECTED AND WHEN APPLIED A LITTLE MORE PRESSURE, IT CRACKED AND THE THUMB WENT THROUGH THE BOTTLE. A NEW BOTTLE WAS PROVIDED AND THERE WAS NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341804 ↗
• MalfunctionFeb 16, 2026Crack

  AS REPORTED, WHEN SURGEON SQUEEZED THE SURGIPHOR BOTTLE DURING TOTAL HIP PROCEDURE, IT CRACKED AND LEAKED ALL OVER THE GLOVES AND GOWN. THE SURGERY WAS PROCEEDED WITH A NEW BOTTLE. THERE WAS NO PATIENT/USER INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341802 ↗
• MalfunctionJan 28, 2026Crack

  AS REPORTED, THREE SURGIPHOR BOTTLES (DEVICE 1, 2 AND 3) CRACKED WHEN SQUEEZED. IT WAS SAID THAT THEIR THUMB WENT RIGHT THROUGH THE PLASTIC. NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199978 ↗
• MalfunctionJan 28, 2026Crack

  AS REPORTED, THREE SURGIPHOR BOTTLES (DEVICE 1, 2 AND 3) CRACKED WHEN SQUEEZED. IT WAS SAID THAT THEIR THUMB WENT RIGHT THROUGH THE PLASTIC. NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199976 ↗
• MalfunctionJan 28, 2026Crack

  AS REPORTED, THREE SURGIPHOR BOTTLES (DEVICE 1, 2 AND 3) CRACKED WHEN SQUEEZED. IT WAS SAID THAT THEIR THUMB WENT RIGHT THROUGH THE PLASTIC. NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199975 ↗
• MalfunctionJan 27, 2026Crack

  IT WAS REPORTED THAT THE SURGIPHOR BROKE IN THE SURGEON¿S HAND DURING IRRIGATION DURING A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2025, FRAGMENTS OF THE BOTTLE WERE OBSERVED WHEN A CRACK OCCURRED, WITH NO APPARENT PATIENT INJURY; THE PRODUCT HAD BEEN STORED ON SHELVES IN THE STERILE STORAGE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191159 ↗
• MalfunctionJan 22, 2026Crack

  PER MEDSUN REPORT: (B)(4): "NO HARM TO PATIENT. WHEN USING THE SURGIPHOR ANTIMICROBIAL IRRIGATION SYSTEM (REF#: 910110, LOT#: 4297341, EXP DATE: 09-30-2026), THE BOTTLE CRACKED WHILE IN SURGEON'S HAND BEING USED AS DIRECTED. THE WOUND WAS IRRIGATED WITH LARGE AMOUNT OF STERILE FLUID AND BOTTLE INSPECTED WITH ALL PIECES INTACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148991 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT 2-3 SURGIPHOR BOTTLES HAVE BROKEN A FEW TIMES AT THE SITE. VIDEO SENT IN SHOWS HEALTH CARE PROFESSIONAL DEMONSTRATING CRACKING OF BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962302 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT 2-3 SURGIPHOR BOTTLES HAVE BROKEN A FEW TIMES AT THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962299 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT 2-3 SURGIPHOR BOTTLES HAVE BROKEN A FEW TIMES AT THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962298 ↗