Blue RhinoRecalls & reported problems across all models
Cook Incorporated · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Blue Rhino model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 4
We found 16 models of Blue Rhino by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between May 26, 2021 and Apr 16, 2026 — classified as 5 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (12 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
Blue Rhino 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 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1780-2026 · Root cause: Incorrect or no expiration date · names 3 of these models · Recall details · FDA record ↗
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1779-2026 · Root cause: Incorrect or no expiration date · names 4 of these models · Recall details · FDA record ↗
- Apr 7, 2023Open, Classified
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
Z-1428-2023 · Root cause: Nonconforming Material/Component · names 5 of these models · Recall details · FDA record ↗
- Apr 7, 2023Open, Classified
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
Z-1427-2023 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗
Most reported Blue Rhino problems
Device problems
- Device-Device Incompatibility12
- Difficult to Advance9
- Difficult to Insert7
- Material Twisted/Bent3
- Deformation Due to Compressive Stress2
- Gas/Air Leak2
- Material Too Soft/Flexible2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information6
- Upper Respiratory Tract Injury4
- Laceration(s)1
- Pneumothorax1
Blue Rhino models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Blue Rhino G57686Tube tracheostomy and tube cuff1 recall9 reports
- Blue Rhino G57703Tube tracheostomy and tube cuff1 recall8 reports
- Blue Rhino G57685Tube tracheostomy and tube cuff1 recall4 reports
- Blue Rhino G57696Tube tracheostomy and tube cuff1 recall2 reports
- Blue Rhino G57716Tube tracheostomy and tube cuff1 recall2 reports
- Blue Rhino G57717Tube tracheostomy and tube cuff1 recall2 reports
- Blue Rhino G57682Tube tracheostomy and tube cuff1 recall1 report
- Blue Rhino G57687Tube tracheostomy and tube cuff1 recall1 report
- Blue Rhino G57704Tube tracheostomy and tube cuff1 recall1 report
- Blue Rhino G57721Tube tracheostomy and tube cuff1 recall1 report
- Blue Rhino G57691Tube tracheostomy and tube cuff1 recall0 reports
- Blue Rhino G57692Tube tracheostomy and tube cuff1 recall0 reports
- Blue Rhino G57695Tube tracheostomy and tube cuff1 recall0 reports
- Blue Rhino G57706Tube tracheostomy and tube cuff1 recall0 reports
- Blue Rhino G57720Tube tracheostomy and tube cuff1 recall0 reports
- Blue Rhino G57725Tube tracheostomy and tube cuff1 recall0 reports
Recent Blue Rhino adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE HEMOSTAT CLAMP IN A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS RUSTED. THE DEVICE WAS REQUIRED FOR A BEDSIDE TRACHEOSTOMY PROCEDURE. UPON OPENING THE TRAY, THE PHYSICIAN DISCOVERED THE CLAMP INSIDE THE KIT WAS COMPLETELY RUSTED. THE PHYSICIAN IMMEDIATELY THREW AWAY THE TRAY AND USED ANOTHER TRAY WITH NO ISSUES. IT WAS NOTED THAT THE LIDOCAINE BOTTLE WAS NOT OPEN OR DAMAGED IN ANY WAY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896007 ↗MalfunctionOct 30, 2025Malposition of Device
THE PHYSICIAN WAS USING A BLUE RHINO DILATOR TO PLACE A NEW TRACHEOSTOMY. THE PHYSICIAN STATED THAT THE WHITE FLEXIBLE TUBING THAT GOES THROUGH THE DILATOR DID NOT STOP AT THE NORMAL STOPPING POINT WHICH CAUSED THE WIRE TO BE PUSHED OUT. THIS PUT THE PATIENT AT RISK FOR LOSING A AIRWAY. PATIENT'S SATURATIONS DROPPED TO 70%.
Patient problems: Laceration(s)
MAUDE report 23423552 ↗MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392663 ↗MalfunctionSep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TIP OF THE 14 FRENCH PUNCH DILATOR INCLUDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET SEPARATED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23005640 ↗MalfunctionAug 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BLUE RHINO DILATOR INCLUDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET ADVANCED OVER THE SAFETY RIDGE OF THE WHITE GUIDING CATHETER DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE FOR A 73-YEAR-OLD, FEMALE PATIENT. THE PHYSICIAN USED THE GRIGGS METHOD TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22914022 ↗MalfunctionAug 25, 2025Difficult to Advance; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22884879 ↗MalfunctionJul 30, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
IN ADDITIONAL INFORMATION RECEIVED ON 12SEP2025, IT WAS REPORTED THAT THE PATIENT HAD NO PREVIOUS SURGERY IN THE LOCATION OF THE TRACHEOSTOMY. THE WHITE GUIDING CATHETER WAS USED WITH THE BLUE RHINO DURING ADVANCEMENT. THE DEVICE WAS USED PER IFU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22668216 ↗MalfunctionJul 29, 2025Difficult to Advance; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648891 ↗MalfunctionJul 29, 2025Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646857 ↗MalfunctionMar 25, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE DILATOR INCLUDED IN THE BLUE RHINO G2- MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS DIFFICULT TO ADVANCE THROUGH THE TRACHEOSTOMY TUBE. THE PHYSICIAN SELECTED AN 8.5 FRENCH (FR) LOADING DILATOR TO MATCH THE 8.5 TRACHEOSTOMY TUBE; HOWEVER, THE DILATOR WAS UNABLE TO ADVANCE THROUGH THE TUBE. A NEW DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS AN USED DEVICE, AND IT WAS CONFIRMED THAT THE IMAGE WAS OF THE FIRST DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691534 ↗InjuryMar 24, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information
IT WAS REPORTED THAT TRACHEAL INJURY OCCURRED DURING USE OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. A 61-YEAR-OLD MALE UNDERWENT A BEDSIDE BRONCHOSCOPY AND PERCUTANEOUS TRACHEOSTOMY PLACEMENT PROCEDURE. THE GUIDE WIRE WAS INSERTED FIRST, AND THEN THE BLUE RHINO DILATOR WAS USED TO FURTHER DILATE THE TRACHEOSTOMY SITE. A #8 CUFFED TRACHEOTOMY TUBE WAS INSERTED AND THEN WAS REMOVED TO CLARIFY THE PLACEMENT. THE BRONCHOSCOPY WAS ADVANCED THROUGH THE ENDOTRACHEAL TUBE (ETT), AND A TEAR IN THE POSTERIOR TRACHEAL WALL WAS VISUALIZED. VENTILATION WAS THEN RESUMED. DIAGNOSTIC STUDIES, INCLUDING A COMPUTED TOMOGRAPHY SCAN AND CHEST X-RAY, AND A THORACIC CONSULT WERE ORDERED. THE PATIENT WAS NOT A SURGICAL CANDIDATE DUE TO HIGH CO-MORBIDITIES AND REQUIRED A DOUBLE LUMEN ETT. PER PHYSICIAN NOTES, BILATERAL CHEST TUBES WERE INSERTED SECONDARY TO THE INCIDENT. THE INDICATION FOR THE RIGHT SIDED CHEST TUBE WAS A PNEUMOTHORAX RESULTING FROM THE INCIDENT. THE LEFT SIDED CHEST TUBE WAS INSERTED AS A PROPHYLACTIC MEASURE SECONDARY TO THE HIGH RISK OF PNEUMOTHORAX. IT IS UNKNOWN IF THE TRACHEAL WALL INJURY WAS CAUSED BY THE WIRE GUIDE OR THE BLUE RHINO DILATOR. THE CUSTOMER BE
Patient problems: Pneumothorax; Upper Respiratory Tract Injury
MAUDE report 21678694 ↗MalfunctionOct 17, 2024Break; Break
ADDITIONAL INFORMATION WAS PROVIDED (B)(6) 2024. THE PRODUCT REGARDING THIS COMPLAINT DID COME INTO CONTACT WITH THE PATIENT. PATIENT INFORMATION WAS NOT ABLE TO BE PROVIDED. THE PATIENT¿S CONDITION FOR REQUIRING TREATMENT WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER LIKE CLAMP DEVICE THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTIONS/PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20472784 ↗MalfunctionJan 17, 2024Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 18530269 ↗MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BLUE RHINO DILATOR OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE DEVICE WAS REQUIRED FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE PLACED IN THE SECOND TRACHEAL SPACE. DURING THE PROCEDURE, THE 14 FRENCH PUNCH DILATOR BENT WHICH CAUSED THE WIRE GUIDE TO KINK. A COMPETITOR'S 14FR DILATOR WAS USED TO CONTINUE THE PROCEDURE. THEN DURING DILATION, THE BLUE RHINO ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE BLUE RHINO WAS REPOSITIONED AT THE SAFETY LEVEL, AND THE PROCEDURE WAS COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18436695 ↗MalfunctionSep 28, 2023Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT THE BLUE RHINO DILATOR OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WAS ADVANCED BEYOND THE SAFETY RIDGE OF THE WHITE GUIDING CATHETER. THIS OCCURRED DURING STOMA CREATION FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE ON A 52-YEAR-OLD MALE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17838323 ↗
Other Cook Incorporated products
All Cook Incorporated devices →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.
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