Surgiphor 910100Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00382909101003), received between Feb 2, 2022 and Oct 2, 2023 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Crack” (26 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Problem with Sterilization; Problem with Sterilization

  VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL AS ATTACHED. THIS IS TO NOTIFY YOU THAT WE HAVE A POTENTIAL SOLUTION STERILITY FAILURE IN TWO COMMERCIAL LOTS OF SURGIPHOR/SURGIRINSE IRRIGATION SYSTEMS (LOT NO. 1817359/ EXPIRATION DATE FEBRUARY 2023 / PART NUMBER 910100 AND LOT NO. 1817360 / EXPIRATION DATE FEBRUARY 2023 / PART NO. 910100) DISCOVERED TODAY. THE TESTING CORRESPONDS WITH PRODUCT AT THE END OF SHELF-LIFE (T = 24 MONTHS) WHICH HAS BEEN STORED UNDER ICH ZONE II CONDITIONS (25°C / 60% RH). THIS IS THE ONLY STABILITY CONDITION TESTED FOR THIS PRODUCT. THESE TWO LOTS ENTERED THE STABILITY PROGRAM IN CALENDAR YEAR 2021 VIA STABILITY PROTOCOL 2021-HP023-PQ AND WERE SENT TO NELSONS LABORATORY TO CONDUCT THE STERILITY TESTING AT T= 24 MONTHS. STERILITY TESTING IS ONLY PERFORMED AT T=0 AND T=24 MONTHS. NELSONS LAB WILL START A FORMAL INVESTIGATION TO DETERMINE IF THE FAILURE IS TRULY REPRESENTATIVE OF THE MICROBIAL CHARACTERISTICS OF THE PRODUCT OR IF THE RESULTS IS DERIVED FROM A LABORATORY ERROR. AS PER OUR LOCAL STABILITY PROCEDURES AT BD EL PASO (0804-003-000-SWI-EP COMMERCIAL FINISHED PRODUCT STABILITY TESTING, SECTION 5.1.9 ), WE NEED TO NOTIFY YOU OF THE POTENTIAL F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851790 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED THAT PATIENT GOT AN INFECTION AFTER USING SURGIPHOR. SPINE DOCTOR WAS OPERATING ON THE PATIENT AND IS NOT KNOWN TO HAVE INFECTIONS ACCORDING TO THE CUSTOMER AND SHE STATES THAT THE PATIENT GOT AN INFECTION AND THE ONLY THING CHANGED WAS THE ADDITION OF SURGIPHOR.

  Patient problems: Post Operative Wound Infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 17578184 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED THAT PATIENT GOT AN INFECTION AFTER USING SURGIPHOR. SPINE DOCTOR WAS OPERATING ON THE PATIENT AND IS NOT KNOWN TO HAVE INFECTIONS ACCORDING TO THE CUSTOMER AND SHE STATES THAT THE PATIENT GOT AN INFECTION AND THE ONLY THING CHANGED WAS THE ADDITION OF SURGIPHOR.

  Patient problems: Unspecified Infection

  MAUDE report 17312844 ↗
• MalfunctionMay 17, 2023Crack; Crack

  TWO SURGIPHOR BOTTLES CRACKED WHILE BEING APPLIED IN THE OPERATIVE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949895 ↗
• MalfunctionApr 7, 2023Crack; Crack

  IT WAS REPORTED THAT A SURGIPHOR IODINE BOTTLE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701507 ↗
• MalfunctionJan 13, 2023Crack; Crack

  THE SQUEEZE BOTTLE BEING ¿BRITTLE¿ AND CRACKING DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159004 ↗
• MalfunctionJan 13, 2023Crack; Crack

  THE SQUEEZE BOTTLE BEING ¿BRITTLE¿ AND CRACKING DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158634 ↗
• MalfunctionJan 12, 2023Crack; Crack

  ANOTHER SURGIPHOR BOTTLE BUSTED DURING A TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154728 ↗
• MalfunctionJan 12, 2023Crack; Crack

  BOTTLE WAS BROKEN AT THE BOTTOM DURING A TKA PROCEDURE. NO IMPACT TO PATIENT, IT BROKE ON THE LAST SQUEEZE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154726 ↗
• MalfunctionJan 12, 2023Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD TWO SURGIPHOR PACKAGES WITH VISIBLE LEAKING WITHIN THE STERILE PACKAGING; TWO BURST WHILE BEING USED IN SURGERY. VERBATIM: TWO SURGIPHOR PACKAGES HAD VISIBLE LEAKING WITHIN THE STERILE PACKAGING. TWO SURGIPHOR'S BURST WHILE BEING USED IN SURGERY, CAUSING THE BETADINE TO SPLASH ALL OVER THE SURGEON AND SCRUB TECH. NO IMPACT ON PATIENT; SURGEON USED THE SURGIPHOR UNTIL IT BURST; LEAKING SURGIPHOR PACKAGES WERE NOT USED. WHEN PRESSURE WAS APPLIED, THE SURGIPHOR BOTTLES BURST IN THE MIDDLE OF THE BOTTLE (PLEASE SEE ATTACHED PHOTO). ADDITIONALLY, THERE WERE TWO INDIVIDUAL SURGIPHOR PACKAGES THAT WERE VISIBLY LEAKING WITHIN THE STERILE PACKAGING (PLEASE SEE ATTACHED PHOTO). THOSE WERE THROWN AWAY AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154725 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLE WAS CRACKED WHILE IN USE DURING A TOTAL JOINT PROCEDURE. WHERE ON THE BOTTLE WAS THE BREAK, I.E., THE CAP, OR THE BOTTLE (CONTAINER)? IF THE BOTTLE, WAS IT AT THE SEAM? BOTTLE. WHAT WAS THE EFFECT ON THE PATIENT IF ANY? NO EFFECT. WAS THERE A SIGNIFICANT PROCEDURAL DELAY? NO. WHAT WAS DONE TO COMPLETE THE IRRIGATION PROCESS? CONTINUED USE. PLEASE PROVIDE ADDRESS THE SAMPLE WILL BE RETURNING FROM - IF AVAILABLE? PLEASE SEND ME THE SHIPPING LABEL. THE BOTTLE CAME FROM /OMIT/.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154590 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLE BUSTED DURING TOTAL HIP REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154589 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLE CRACKED/BROKE DURING APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154547 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLES BUSTED DURING TKA. NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154546 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLES BUSTED DURING 2 TOTAL HIP REPLACEMENTS. CUSTOMER RESPONSE. WHERE ON THE BOTTLE WAS THE BREAK, I.E., THE CAP, OR THE BOTTLE (CONTAINER)? IF THE BOTTLE, WAS IT AT THE SEAM? ONE BOTTLE, ONE CAP AREA (HOLE TOO LARGE, CAUSED LEAK). PLEASE PROVIDE MATERIAL/LOT NUMBER ¿ IF AVAILABLE? N/A. WHAT WAS THE EFFECT ON THE PATIENT IF ANY? NO EFFECT. WAS THERE A SIGNIFICANT PROCEDURAL DELAY? NO. WHAT WAS DONE TO COMPLETE THE IRRIGATION PROCESS? CONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154544 ↗
• MalfunctionJan 12, 2023Crack; Crack

  THE SURGIPHOR BOTTLE BUSTED WHEN THE SURGEON SQUEEZED IT. THEY SAID IT WAS DENTED IN WHEN THEY OPENED THE PRODUCT AND THEN WHEN THE SURGEON TRIED TO USE IT, IT SPRAYED EVERYWHERE. BOTTLE WAS BUSTED, BUT IT DID NOT CAUSE ANY PHYSICAL HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154380 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLES ARE BREAKING NEAR THE NECK OF THE BOTTLE WHEN SQUEEZED. THIS IS ONLY HAPPENING WITH THE SURGIPHOR BOTTLE, NOT THE SURGIRINSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154320 ↗
• MalfunctionJan 12, 2023Crack; Crack

  SURGIPHOR BOTTLE CRACKED WHILE IN USE. NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153634 ↗
• MalfunctionJan 12, 2023Crack; Crack

  IT WAS REPORTED THAT BOTTLE BROKE WHILE USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153633 ↗
• MalfunctionJan 12, 2023Crack; Crack

  WHILE SQUEEZING THE SURGIPHOR BOTTLE IT BROKE WITH ABOUT 50ML REMAINING IN THE BOTTLE. THE BREAK WAS ON THE BOTTLE ALONG THE SIDE, NOT SURE IF SEAM OR NOT. KIND OF SHATTERED NO EFFECT AS OF YET. SOME SOLUTION SPLATTERED ON OVERHEAD LIGHTS, THEN DRIPPED ON FIELD. MINIMAL DELAY REMAINDER OF SOLUTION USED FOR IRRIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153500 ↗
• MalfunctionJan 12, 2023Crack; Crack

  IT WAS REPORTED THAT A SURGIPHOR BOTTLE BROKE / EXPLODED WHEN THEY SQUEEZED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151227 ↗
• MalfunctionJan 12, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT A COUPLE SURGIPHOR BOTTLES BROKE AT THE SEAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148761 ↗
• MalfunctionJan 12, 2023Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER THAT 3 BOTTLES OF SURGIPHOR CRACKED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147884 ↗
• MalfunctionJan 12, 2023Crack; Crack

  A BOTTLE BURST WHILE BEING SQUEEZED DURING APPLICATION OF PRODUCT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147273 ↗
• MalfunctionJan 11, 2023Crack; Crack

  ORTHOPEDIC SURGEON USED SURGIPHOR FOR KNEE WASHOUT. SQUEEZED THE BOTTLE AND THE BODY OF THE BOTTLE CRACKED AS THE LAST REMNANTS OF SOLUTION WERE BEING EXPRESSED. THERE WAS NO COMPROMISE TO THE BOTTLE CAP. THE SURGEON WAS SQUEEZING IT FROM THE DISTAL END OF THE BOTTLE HOLDING IT DOWNWARD AND NOT FROM THE BODY OF THE BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140580 ↗