CONMED 0036550Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10653405000525), received between Oct 11, 2016 and May 1, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2023Contamination

  CONMED SUCTION TUBING, STERILE PACKET OPENED. WHEN THE END OF THE TUBING WAS VISUALIZED- A BLACK SUBSTANCE WAS NOTED INSIDE. IT WAS A LARGE AMOUNT OF THICK, BLACK DEBRIS ATTACHED TO THE INSIDE OF THE TUBING. THIS WAS NOT ATTACHED TO SUCTION SO NO PATIENT HARM. MANUFACTURER RESPONSE FOR TUBE, ASPIRATING, FLEXIBLE, CONNECTING, NA (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843369 ↗
• MalfunctionAug 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036550, 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 15248045 ↗
• MalfunctionAug 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036550, 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 15190109 ↗
• MalfunctionMar 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036550, 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 13695040 ↗
• MalfunctionSep 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036550, 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 12553508 ↗
• MalfunctionAug 26, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036550, FOR AN INSUFFICIENT HEAT-SEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370404 ↗
• MalfunctionJul 15, 2020Device Contamination with Chemical or Other Material

  CONMED TUBING, UNOPENED PACKAGE WITH EVIDENCE OF HAIR, VISIBLE THROUGH PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10277550 ↗
• MalfunctionFeb 22, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(6) REJECTED ONE 0036550 SURGICAL TUBING DUE TO AN "INSUFFICIENT HEATSEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7288857 ↗
• MalfunctionMar 30, 2017Device Packaging Compromised; Device Packaging Compromised

  AS REPORTED BY THE DISTRIBUTOR IN (B)(4), ONE (1) 1/4" X 12' SUCTION TUBING PACKAGE WAS DISCOVERED TO HAVE AN "INSUFFICIENT HEATSEAL OR BLISTER PACK." THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6446302 ↗
• MalfunctionFeb 1, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 1PACKAGE CONTAINING 1/4" X 12' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO THE END-USER. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6294300 ↗
• MalfunctionOct 11, 2016Device Packaging Compromised; Packaging Problem

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 4 PACKAGES CONTAINING 1/4" X 12' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 6016906 ↗