FRAZIERRecalls & reported problems across all models
Conmed Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 7 models of FRAZIER by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2018 and Jun 12, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. 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 FRAZIER problems
Device problems
- Delivered as Unsterile Product26
- Tear, Rip or Hole in Device Packaging2
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Patient Involvement3
- No Known Impact Or Consequence To Patient1
FRAZIER models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FRAZIER 0033120APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED11 reports
- FRAZIER 0033100APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED10 reports
- FRAZIER 0033080APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED4 reports
- FRAZIER 0031100APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 reports
- FRAZIER 0031070APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- FRAZIER 0033100APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- FRAZIER 0033180APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
Recent FRAZIER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033180, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484633 ↗MalfunctionMar 12, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578527 ↗MalfunctionSep 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE 0033100 SURGICAL SUCTION INSTRUMENT, 10FR W/CONTROL VENT & OBTURATOR, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037024 ↗MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908618 ↗MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033120, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908612 ↗MalfunctionMar 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR REPORTED THAT THE 0033120 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. THE SHIPMENT ASSOCIATED WITH THE RGA FOR THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AND IT HAS NOT BEEN CONFIRMED THAT AN INSUFFICIENT HEATSEAL CAUSING A STERILITY BREACH HAS OCCURRED. BASED ON THE INFORMATION AVAILABLE, AND THE DECISION TREE RESULTS, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. UPON THE RECEIPT OF THE DEVICE, AN EVALUATION WILL BE CONDUCTED AND IF A BREACH OF STERILITY IS CONFIRMED THE REPORTING DECISION WILL BE REASSESSED AT THAT TIME. UPDATE: 19 FEB 2025 - THE DEVICE HAS BEEN RETURNED AND AN EVALUATION HAS BEEN COMPLETED. AN INSUFFICIENT HEATSEAL WAS DISCOVERED AFTER TESTING. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21617362 ↗MalfunctionJan 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, (B)(6), SURGICAL SUCTION INSTRUMENT, 12FR W/CONTROL VENT & & OBTURATOR, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208647 ↗MalfunctionDec 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033100, SURGICAL SUCTION INSTRUMENT, 10FR W/CONTROL VENT & OBTURATOR, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20852342 ↗MalfunctionSep 6, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20155640 ↗MalfunctionJan 19, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED TWO DEVICES, 0033100, FRAZIER INSTRUMENT 10 FRENCH 50/CASE, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18545095 ↗MalfunctionDec 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033080, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18362916 ↗MalfunctionOct 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033120, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. . PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17974508 ↗MalfunctionOct 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17974506 ↗MalfunctionAug 2, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033080, FOR AN INSUFFICIENT HEATSEAL. THE DEVICE WAS ENCROACHING THE SEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17443463 ↗MalfunctionApr 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16818067 ↗
Other Conmed Corporation products
All Conmed Corporation 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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