CONMEDRecalls & reported problems across all models
Unimax Medical Systems Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CONMED model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of CONMED by Unimax Medical Systems Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2020 and Jun 21, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (7 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
CONMED 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 25, 2024Open, Classified
The tube may fall into the surgical site during the grasping process.
Z-3164-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported CONMED problems
Device problems
- Break7
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Laceration(s)1
- No Consequences Or Impact To Patient1
CONMED models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONMED SB979Laparoscope, General & Plastic Surgery1 recall1 report
- CONMED SB957Laparoscope, General & Plastic Surgery1 recall0 reports
- CONMED SB534Laparoscope, General & Plastic Surgery4 reports
- CONMED SB936Laparoscope, General & Plastic Surgery2 reports
- CONMED SB1079Laparoscope, General & Plastic Surgery1 report
Recent CONMED adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2026Break
THE STRING BROKE WHEN TRYING TO REMOVE SPECIMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25572664 ↗MalfunctionJun 10, 2026Break
THE BAG RIPPED AT THE BOTTOM WITHOUT ANY INSTRUMENTS PIERCING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25454097 ↗MalfunctionFeb 4, 2026Break
THE ENDOCATCH BAG (SIZE 3" BY 6", 10MM, 330ML) RIPPED WHILE PULLING OUT SPECIMEN FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256073 ↗MalfunctionJan 29, 2026Break
THE RETRIEVAL BAG BEING USED TO OBTAIN APPENDIX IN A LAP APPY CASE. BAG BROKE OPEN WHEN TRYING TO REMOVE THE SPECIMEN. TRIED WITH A NEW BAG AND HAPPENED AGAIN. SPECIMEN WAS REMOVED BY SURGICAL INSTRUMENT FROM ABDOMEN BY DOCTOR AFTER THE BAGS FAILED. SURGICAL TEAM EXAMINED SPECIMEN BAG, DID NOT APPEAR TO BE MISSING ANY PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24207328 ↗MalfunctionDec 12, 2025Break; Break
DURING THE PROCEDURE, THE STRINGS BROKE ON THE BAG. THEY BELIEVE THE PRONGS ON THE BAG CAUSED A BOWEL INJURY RESULTING IN A SIGMOID COLECTOMY.
Patient problems: Laceration(s)
MAUDE report 23787375 ↗MalfunctionNov 11, 2025Break; Break
THE 5MM BAG RIPPED WHILE TRYING TO GET THE SPECIMEN OUT. THE DEVICE WAS USED IN A LAPAROSCOPIC CHOLECYSTECTOMY WHICH WAS COMPLETED WITHOUT ANY REPORT OF DELAY. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519966 ↗MalfunctionJul 17, 2025Break; Break
BAG SHREDDED INSIDE PATIENT'S BODY DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22538875 ↗MalfunctionJun 15, 2020Material Fragmentation; Material Fragmentation
VOLUNTARY DISTRIBUTOR REPORT: ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE 3X4 MINI ENDO POCKET BAG, ITEM SB534, LOT 6251903128. IT WAS REPORTED ONLY THAT A PIECE OF PLASTIC BREAKS OFF AND FALLS INTO THE PATIENT WHEN THE BAG IS BEING DEPLOYED. ADDITIONAL INFORMATION PROVIDED INDICATES THE ISSUE OCCURRED ON (B)(6) 2020 DURING A ROBOTIC CHOLECYSTECTOMY. WHILE THE SPECIMEN WAS BEING REMOVED THROUGH THE INCISION, THE PLASTIC PIECE SPLINTERED EITHER DURING OR JUST AFTER THE REMOVAL OF THE SPECIMEN. IT WAS CLARIFIED THAT THE PIECE IN QUESTION NEVER BROKE OR FELL INSIDE THE PATIENT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT, NO INDICATION OF THE SPECIMEN FALLING OUT OR FRAGMENTATION OF THE BAG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE DEVICE IN QUESTION WAS DISCARDED. THE SIZE OF THE TROCAR IS UNKNOWN AND STANDARD ROBOTIC INSTRUMENTS LIKE A GRASPER WERE BEING USED AT THE TIME. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10153859 ↗
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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