Ballard* Turbo-Cleaning Closed Suction SystemRecalls & reported problems across all models
Avanos Medical, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Ballard* Turbo-Cleaning Closed Suction System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 123
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls
- 3
We found 16 models of Ballard* Turbo-Cleaning Closed Suction System by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 123 adverse event reports in the FDA's MAUDE database, received between Jul 1, 2020 and Sep 16, 2026 — classified as 1 death, 9 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Disconnection” (46 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
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
Ballard* Turbo-Cleaning Closed Suction System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 19, 2025Open, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1528-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2025Open, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1527-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2025Open, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1526-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Ballard* Turbo-Cleaning Closed Suction System problems
Device problems
- Disconnection46
- Suction Problem27
- Suction Failure9
- Break8
- Material Integrity Problem5
- Material Too Soft/Flexible5
- Obstruction of Flow5
- Gas/Air Leak4
Patient problems
- No Consequences Or Impact To Patient45
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information23
- No Known Impact Or Consequence To Patient5
- Bradycardia2
- Foreign Body In Patient2
- Hypoventilation2
- Hypoxia2
Ballard* Turbo-Cleaning Closed Suction System models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ballard* Turbo-Cleaning Closed Suction System 98965CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall16 reports
- Ballard* Turbo-Cleaning Closed Suction System 98263CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall11 reports
- Ballard* Turbo-Cleaning Closed Suction System 98264CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall0 reports
- Ballard* Turbo-Cleaning Closed Suction System 94701CATHETERS, SUCTION, TRACHEOBRONCHIAL33 reports
- Ballard* Turbo-Cleaning Closed Suction System 93839CATHETERS, SUCTION, TRACHEOBRONCHIAL1 death26 reports
- Ballard* Turbo-Cleaning Closed Suction System 98977CATHETERS, SUCTION, TRACHEOBRONCHIAL14 reports
- Ballard* Turbo-Cleaning Closed Suction System 92481CATHETERS, SUCTION, TRACHEOBRONCHIAL7 reports
- Ballard* Turbo-Cleaning Closed Suction System 98255CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Ballard* Turbo-Cleaning Closed Suction System 99734CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Ballard* Turbo-Cleaning Closed Suction System 98969CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Turbo-Cleaning Closed Suction System 98970CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Turbo-Cleaning Closed Suction System 98978CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Turbo-Cleaning Closed Suction System 98265CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Turbo-Cleaning Closed Suction System 98885CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Turbo-Cleaning Closed Suction System 98981CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Turbo-Cleaning Closed Suction System 98983CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
Recent Ballard* Turbo-Cleaning Closed Suction System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Integrity Problem
Patient problems: Insufficient Information
MAUDE report 50795032 ↗MalfunctionFeb 19, 2025Increase in Suction; Increase in Suction
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2025-00017 FOR THE SECOND REPORT. REFER TO 8030647-2025-00018 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21413013 ↗MalfunctionFeb 19, 2025Increase in Suction; Increase in Suction
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2025-00016 FOR THE FIRST REPORT. REFER TO 8030647-2025-00017 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21412996 ↗MalfunctionFeb 19, 2025Increase in Suction; Increase in Suction
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2025-00016 FOR THE FIRST REPORT. REFER TO 8030647-2025-00018 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21412992 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED, THE CLOSED SUCTION CATHETER SNAPPED (AT THE PATIENT END) DURING USE; THE DEVICE WAS REPLACED FOR A NEW ONE; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21072943 ↗MalfunctionDec 30, 2024Break; Break
IT WAS REPORTED, THE CLOSED SUCTION CATHETER SNAPPED OFF AT THE BUTTON END; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21044709 ↗MalfunctionDec 24, 2024Break; Break
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2024-00096 FOR THE FIRST REPORT. IT WAS REPORTED; THE TUBE BROKE/ SNAPPED AT THE ON/OFF BUTTON END; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21014412 ↗MalfunctionDec 24, 2024Break; Break
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2024-00097 FOR THE SECOND REPORT. IT WAS REPORTED, THE TUBE BROKE/ SNAPPED AT THE ON/OFF BUTTON END; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21014411 ↗MalfunctionNov 19, 2024Suction Failure; Suction Failure
IT WAS REPORTED, THE PATIENT WAS NOT ABLE TO BE ASPIRATED; THE DEVICE, WHICH HAD BEEN IN PLACE FOR LESS THAN 20 HOURS, WAS CHANGED; THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20723719 ↗MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT . IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990752 ↗MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990750 ↗MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT. REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990748 ↗MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT. REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990736 ↗MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT . REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990734 ↗MalfunctionAug 5, 2024Suction Failure; Suction Failure
IT WAS REPORTED, THE DEVICE DID NOT SUCTION, THERE WAS A DELAY IN SUCTIONING THE PATIENT; HOWEVER, THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19911608 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Closed Suction System for Adults17 models · 121 reports · 3 recalls
- CORTRAK* 2 Enteral Access System2 models · 134 reports · 1 recall
- Cortrak 2 Enternal access device14 models · 164 reports
- NEOMED*24 models · 0 reports · 3 recalls
- Microcuff* Endotracheal Tube for Adults8 models · 102 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW*2 models · 94 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page