SurgiphorRecalls & reported problems across all models
Carefusion 2200, Inc · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 171
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 2 models of Surgiphor by Carefusion 2200, Inc in the FDA's device registry (GUDID). Together they are named in 171 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2022 and Aug 5, 2026 — classified as 4 injuries, 167 malfunctions.
The most frequently reported specific device problem is “Crack” (157 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. 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
Most reported Surgiphor problems
Device problems
- Crack157
- Adverse Event Without Identified Device or Use Problem8
- Use of Device Problem2
- Contamination1
- Contamination /Decontamination Problem1
- Fungus in Device Environment1
- Leak/Splash1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions161
- Rash5
- Insufficient Information2
- Unspecified Infection2
- Post Operative Wound Infection1
- Purulent Discharge1
- Wound Dehiscence1
Surgiphor models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surgiphor 910110LAVAGE, JET140 reports
- Surgiphor 910100LAVAGE, JET31 reports
Recent Surgiphor adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Carefusion 2200, Inc products
All Carefusion 2200, 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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