ONETRAC LXS C110220Recalls & reported problems
Obp Corporation · ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE · Class 2
Data updated Oct 18, 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 M648C1102200), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
COMPANY RECEIVED A COPY OF MEDWATCH FDA CARS GENERATED 3500-SERIES FORM - PROBLEM REPORT FROM MEDICAL DEVICE REPORTING TEAM, CDRH. PROBLEM DESCRIBED ON FORM AS FOLLOWS, "THE PRODUCT FROM OBP SURGICAL, "ONETRAC LXS YANKAUER" SHOULD BE STERILE AND INSIDE OF A STERILE PACKAGE. HOWEVER, ON NUMEROUS OCCASIONS STERILITY HAS BEEN COMPROMISED. IT HAS BEEN NOTED THAT THERE HAS BEEN HUMAN HAIR, AND OTHER DEBRIS INSIDE OF THE STERILE PACKAGING WHICH COULD RISK INFECTIONS AND OTHER COMPLICATIONS FOR THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20294718 ↗
Other Catheter And Tip, Suction devices
- J-VAC 2160Ethicon Inc. · CATHETER AND TIP, SUCTION152 reports
- Wayne G56537Cook Incorporated · CATHETER AND TIP, SUCTION2 recalls33 reports
- Bard® Suction Connector EN0066000C. R. Bard, Inc. · CATHETER AND TIP, SUCTION1 recall6 reports
- Medline Industries, Inc. OR929KMedline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- MEDLINE DYND41476Medline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- ARROW IPN039282Teleflex Incorporated · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 10102Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12082Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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