HalyardRecalls & reported problems across all models
Avanos Medical, Inc. · 232 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,210
- Deaths reported
- 30
- Injuries reported
- 159
- Recalls
- 1
We found 232 models of Halyard by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,210 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2016 and Jun 11, 2026 — classified as 30 deaths, 159 injuries, 1,021 malfunctions.
The most frequently reported specific device problem is “Break” (300 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Halyard 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 21, 2022Class ITerminated
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
Z-1032-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported Halyard problems
Device problems
- Break300
- Infusion or Flow Problem196
- Excess Flow or Over-Infusion119
- Adverse Event Without Identified Device or Use Problem99
- Disconnection71
- Detachment of Device or Device Component69
- Malposition of Device51
- Inflation Problem35
Patient problems
- No Known Impact Or Consequence To Patient514
- No Consequences Or Impact To Patient249
- No Code Available77
- Foreign Body In Patient46
- Pneumothorax37
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information32
- Device Embedded In Tissue or Plaque30
Halyard models
232 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Halyard 13222Tube, Tracheal (W/Wo Connector)2 deaths93 reports
- Halyard 47201TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall4 deaths39 reports
- Halyard 13568PUMP, INFUSION, ELASTOMERIC86 reports
- Halyard 13472PUMP, INFUSION, ELASTOMERIC68 reports
- Halyard 13221Tube, Tracheal (W/Wo Connector)1 death64 reports
- Halyard 47206TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Halyard 13903CATHETER AND TIP, SUCTION1 death49 reports
- Halyard 13561PUMP, INFUSION, ELASTOMERIC42 reports
- Halyard 98701TUBE, GASTRO-ENTEROSTOMY1 death40 reports
- Halyard 98431TUBE, GASTRO-ENTEROSTOMY35 reports
- Halyard 98433TUBE, GASTRO-ENTEROSTOMY27 reports
- Halyard 13220Tube, Tracheal (W/Wo Connector)2 deaths25 reports
- Halyard 13566PUMP, INFUSION, ELASTOMERIC24 reports
- Halyard 35111Tube, Tracheal (W/Wo Connector)21 reports
- Halyard 45799TUBES, GASTROINTESTINAL (AND ACCESSORIES)5 deaths20 reports
- Halyard 98430TUBE, GASTRO-ENTEROSTOMY20 reports
- Halyard 13476PUMP, INFUSION, ELASTOMERIC1 death19 reports
- Halyard 13685PUMP, INFUSION, ELASTOMERIC19 reports
- Halyard 98434TUBE, GASTRO-ENTEROSTOMY19 reports
- Halyard 13535CATHETER, CONDUCTION, ANESTHETIC18 reports
- Halyard 35112Tube, Tracheal (W/Wo Connector)17 reports
- Halyard 98432TUBE, GASTRO-ENTEROSTOMY16 reports
- Halyard 35216Tube, Tracheal (W/Wo Connector)15 reports
- Halyard 13477PUMP, INFUSION, ELASTOMERIC1 death14 reports
- Halyard 13904CATHETER AND TIP, SUCTION12 reports
- Halyard 35215Tube, Tracheal (W/Wo Connector)11 reports
- Halyard 44280PUMP, INFUSION, ELASTOMERIC10 reports
- Halyard 13474PUMP, INFUSION, ELASTOMERIC9 reports
- Halyard 13483PUMP, INFUSION, ELASTOMERIC9 reports
- Halyard 35113Tube, Tracheal (W/Wo Connector)9 reports
- Halyard 13539CATHETER, CONDUCTION, ANESTHETIC2 deaths7 reports
- Halyard 97021CATHETER AND TIP, SUCTION7 reports
- Halyard 13473PUMP, INFUSION, ELASTOMERIC6 reports
- Halyard 13479PUMP, INFUSION, ELASTOMERIC6 reports
- Halyard 13563PUMP, INFUSION, ELASTOMERIC6 reports
- Halyard 35214Tube, Tracheal (W/Wo Connector)6 reports
- Halyard 40784Anesthesia conduction kit5 reports
- Halyard 40977TUBES, GASTROINTESTINAL (AND ACCESSORIES)5 reports
- Halyard 44271PUMP, INFUSION, ELASTOMERIC5 reports
- Halyard 98437TUBE, GASTRO-ENTEROSTOMY5 reports
- Halyard 97020CATHETER AND TIP, SUCTION5 reports
- Halyard 13223Tube, Tracheal (W/Wo Connector)4 reports
- Halyard 13533CATHETER, CONDUCTION, ANESTHETIC4 reports
- Halyard 13560PUMP, INFUSION, ELASTOMERIC4 reports
- Halyard 13565PUMP, INFUSION, ELASTOMERIC4 reports
- Halyard 13646PUMP, INFUSION, ELASTOMERIC4 reports
- Halyard 13672PUMP, INFUSION, ELASTOMERIC4 reports
- Halyard 13676PUMP, INFUSION, ELASTOMERIC4 reports
- Halyard 35114Tube, Tracheal (W/Wo Connector)4 reports
- Halyard 40792Anesthesia conduction kit4 reports
- Halyard 44292TUBES, GASTROINTESTINAL (AND ACCESSORIES)4 reports
- Halyard 46082TUBES, GASTROINTESTINAL (AND ACCESSORIES)4 reports
- Halyard 95640TUBES, GASTROINTESTINAL (AND ACCESSORIES)4 reports
- Halyard 98606ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Halyard 13480PUMP, INFUSION, ELASTOMERIC3 reports
- Halyard 13554PUMP, INFUSION, ELASTOMERIC3 reports
- Halyard 13623PUMP, INFUSION, ELASTOMERIC1 death3 reports
- Halyard 13713PUMP, INFUSION, ELASTOMERIC3 reports
- Halyard 32771Anesthesia conduction kit3 reports
- Halyard 35115Tube, Tracheal (W/Wo Connector)3 reports
- Halyard 40778Anesthesia conduction kit3 reports
- Halyard 40978TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Halyard 44195PROBE, RADIOFREQUENCY LESION3 reports
- Halyard 44949PUMP, INFUSION, ELASTOMERIC3 reports
- Halyard 46042TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Halyard 46094TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Halyard 92794General surgery tray (kit)3 reports
- Halyard 94845TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Halyard 95480TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death3 reports
- Halyard 95664TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
- Halyard 96897CATHETER AND TIP, SUCTION3 reports
- Halyard 10226TUBE, GASTRO-ENTEROSTOMY2 reports
- Halyard 13630PUMP, INFUSION, ELASTOMERIC2 reports
- Halyard 13718PUMP, INFUSION, ELASTOMERIC2 reports
- Halyard 13721PUMP, INFUSION, ELASTOMERIC2 reports
- Halyard 31614PUMP, INFUSION, ELASTOMERIC2 reports
- Halyard 35117Tube, Tracheal (W/Wo Connector)2 reports
- Halyard 35212Tube, Tracheal (W/Wo Connector)2 reports
- Halyard 39228Anesthesia conduction kit2 reports
- Halyard 40787Anesthesia conduction kit2 reports
- Halyard 40979TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 44939PUMP, INFUSION, ELASTOMERIC2 reports
- Halyard 45758TUBE, FEEDING2 reports
- Halyard 45835TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 46017TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 46037TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 46097TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 47168TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94782TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death2 reports
- Halyard 94809TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94821TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death2 reports
- Halyard 94829TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94842TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94846TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94927TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94967TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 94975TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death2 reports
- Halyard 95637TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 95647TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Halyard 95668TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
Recent Halyard adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Material Split, Cut or Torn
IT WAS REPORTED, THERE WAS A TEAR UNDER Y-CONNECTOR. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477363 ↗MalfunctionJun 3, 2026Leak/Splash
IT WAS REPORTED, "THERE WAS A LEAK FROM NG TUBE DURING FIRST TIME ADMINISTRATION." NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 25382336 ↗MalfunctionJun 3, 2026Leak/Splash
IT WAS REPORTED, "THERE WAS A TEAR ON NG [NASOGASTRIC] TUBE AND LEAKAGE OCCURRED DURING USE."
Patient problems: Insufficient Information
MAUDE report 25382318 ↗MalfunctionMay 29, 2026Leak/Splash
THE CUSTOMER REPORTED THAT LEAKAGE WAS OBSERVED FROM AN NASOGASTRIC TUBE AFTER APPROXIMATELY TWO WEEKS OF USE. THE LOCATION OF THE LEAK WAS UNKNOWN. THE DEVICE WAS REPLACED WITH ANOTHER TUBE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334472 ↗MalfunctionMay 4, 2026Material Puncture/Hole
IT WAS REPORTED "THERE WAS A TEAR ON [NASOGASTRIC] TUBE. IT WAS REPORTED THAT A USER DID NOT LUBRICATE THE TUBE WITH WATER DURING REMOVING STYLET. NO PATIENT INJURY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073579 ↗MalfunctionApr 16, 2026Material Rupture
I WAS REPORTED THERE WAS A TEAR ON THE NASOGASTRIC TUBE. "IT WAS REPORTED THAT A USER DID NOT LUBRICATE THE TUBE WITH WATER DURING REMOVING STYLET." THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896450 ↗MalfunctionApr 16, 2026Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT A LEAK WAS NOTICED. THERE WERE 3 HOLES NOTED IN THE TUBE NEAR THE ENTRY PORT. IT TURNS OUT THE NURSE DID NOT LUBRICATE THE TUBE FOR GUIDEWIRE REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895983 ↗MalfunctionJan 14, 2025Break; Break
ADDITIONAL INFORMATION (B)(6) 2025 STATED THE DISTAL TIP OF DILATOR WAS SUPPOSEDLY RETAINED IN THE ESOPHAGEAL WALL OR ABDOMINAL CAVITY. "THE OPERATION WAS PERFORMED ENDOSCOPICALLY, AND GUIDEWIRE WAS USED.".
Patient problems: Foreign Body In Patient
MAUDE report 21148586 ↗MalfunctionJan 9, 2025Material Disintegration; Material Disintegration
A REPORT WAS RECEIVED FROM THE CUSTOMER THAT ALLEGES THE DRAPE WINDOW WAS SEPARATING WHERE THE WINDOW JOINS MATERIAL. THIS INCIDENT COMPROMISED STERILITY DURING THE PROCEDURE. THE CUSTOMER REPORTED THERE WERE THREE LOTS OF DRAPE UTILIZED INCLUDING: GL22282FXX, GL21331FXX & GL23098FXX; HOWEVER, THE CUSTOMER COULD NOT VERIFY WHICH LOT WAS THE ONE THAT EXHIBITED THIS ISSUE DURING PROCEDURE. THE CUSTOMER INDICATED THERE WAS NO PATIENT INJURY OR MEDICAL TREATMENT REQUIRED, ONLY AN IMPACT TO THE STERILE FIELD DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120752 ↗InjuryJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED THAT THE NODE NAVIGATOR WAS PROPERLY DRAPED AND SECURED WITH VIDEO DRAPE. DURING RIGHT SEED LOCALIZED PARTIAL MASTECTOMY PROCEDURE, IT WAS NOTED BY THE SURGEON THAT THE PERFORATED END OF THE VIDEO DRAPE WAS SEPARATED. THIS CAUSED THE PROBE TO BE EXPOSED. THE PROCEDURE WAS EXTENDED DUE TO HAVING TO REESTABLISH STERILE FIELD AND RE-WRAP THE PROBE WITH DRAPE. STAFF HAVE STARTED RELOCATING THE PROBE END TO ANOTHER LOCATION AND SECURING WITH THE STERILE TAPE PROVIDED IN THE DRAPE KIT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19557214 ↗InjuryFeb 14, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED, ¿INCORRECT INSERTION INTO LUNG OCCURRED. VERY SMALL AMOUNT OF NUTRITION WAS MIS-ADMINISTERED INTO LUNG. THE MONITOR SHOWED THE INCORRECT INSERTION, BUT IT WAS NOT NOTICED DURING THE INSERTION AND ALSO FROM X-RAY DATA AFTER INSERTION.¿ NO MEDICAL INTERVENTIONS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18705519 ↗InjuryJan 12, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED AN UNSPECIFIED INJURY OCCURRED WHEN THE CORTRAK 2 EAS WAS IN USE. THE USER NOTED A POTENTIAL CONTRIBUTING FACTOR OF THE PATIENT INJURY WAS THE PATIENT WAS "INTUBATED." NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18505946 ↗MalfunctionNov 22, 2023Premature Separation; Premature Separation
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2023-00169 FOR THE FIRST REPORT. IT WAS REPORTED, T-BAR CAME OFF. IT WAS SUPPOSED THAT THE SUTURE SNAPPED AT THE CONNECTION PART BETWEEN T-BAR AND THE SUTURE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18193854 ↗MalfunctionNov 22, 2023Premature Separation; Premature Separation
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2023-00170 FOR THE SECOND REPORT. IT WAS REPORTED, T-BAR CAME OFF AFTER A FEW HOURS OF OPERATION. IT WAS SUPPOSED THAT THE SUTURE SNAPPED AT THE CONNECTION PART BETWEEN T-BAR AND THE SUTURE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18193849 ↗MalfunctionNov 6, 2023Migration; Migration
IT WAS REPORTED A "GASTROSTOMY OPERATION WITH VENTROSCOPY WAS PERFORMED. AT THAT TIME THE PATIENT'S STOMACH WAS PULLED UP WITH A DEVICE LIKE FORCEPS TO MAKE A GASTRIC STOMA SITE. AFTER THE OPERATION, T-BAR WAS MIGRATED. ANCHOR WAS CUT AND THE T-BAR WAS REMOVED WITH AN ENDOSCOPE AND FIXED WITH SUTURE INSTEAD. (SUTURE WAS ALREADY REMOVED) NOW THERE IS NO PROBLEM WITH ADMINISTERING NUTRITION."
Patient problems: Foreign Body In Patient
MAUDE report 18074943 ↗
Other Avanos Medical, Inc. products
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 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-FLOW2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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