FRAZIER 0033100 (UDI 30653405000123)Recalls & reported problems
Conmed Corporation · FRAZIER Suction Instrument 10 Fr W/Control Vent & Obturator · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30653405000123), received between Dec 13, 2021 and Sep 12, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (10 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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗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 ↗MalfunctionJan 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 16247456 ↗MalfunctionNov 18, 2022Delivered 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 15824249 ↗MalfunctionDec 13, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 0033100, LOT 202006221, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN JAPAN. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12987744 ↗
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- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
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- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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