FRAZIER 0031070Recalls & reported problems
Conmed Corporation · FRAZIER Suction Instrument 7 Fr W/Control Vent & Obturator · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405000079), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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
Device problems
- Delivered as Unsterile Product1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2018Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR IN (B)(4) REPORTED A "TEAR" ON THE STERILE POUCH OF DEVICE (B)(4). THIS WOULD BE AN OBVIOUS DEFECT TO THE USER AND WAS THEREFORE NOT DEEMED A REPORTED DEVICE FAILURE. HOWEVER, THE COMPLAINT DEVICE WAS RETURNED TO CONMED FOR EVALUATION AND A HOLE WAS FOUND IN THE PACKAGING THAT WAS LIKELY CAUSED BY THE DEVICE. NO PATIENT INVOLVEMENT AS THIS DEFECT WAS FOUND DURING INCOMING INSPECTION. THIS INCIDENT WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY.
Patient problems: No Patient Involvement
MAUDE report 7613685 ↗
Other APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED devices
- StrykeFlow 0250070520Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 recalls250 reports
- StrykeFlow 0250070505Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall3 reports
- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571315Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- CRD 65651-510Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page