Blue Rhino G57703Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002577039), received between Apr 24, 2023 and Apr 16, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K193133); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 5, 2026Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, 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 ↗
• MalfunctionJul 17, 2023Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION IN AN OPENED CONDITION. DURING THE DEVICE INVESTIGATION, IT WAS DETERMINED THAT PARTS WERE NOT RETURNED IN THE TRAY (GAUZE AND DRAPE). ADDITIONALLY, THE BLUE RHINO DILATOR ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE GUIDING CATHETER ALSO HAD SEVERAL AREAS THAT WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333760 ↗
• MalfunctionJul 17, 2023Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION IN AN OPENED CONDITION. DURING THE DEVICE INVESTIGATION IT WAS DISCOVERED THAT THE BLUE RHINO DILATOR ADVANCED WITH SLIGHT RESISTANCE OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE SAFETY RIDGE OF THE GUIDING CATHETER WAS FLATTENED/SMASHED.

  Patient problems: Insufficient Information

  MAUDE report 17333694 ↗
• MalfunctionMay 30, 2023Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  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 17020218 ↗
• InjuryApr 24, 2023Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED 26APR2023 REGARDING THE THREE EVENTS. THIS REPORT WILL FOCUS ON AN EVENT REPORTED BY ONE OF THE PHYSICIANS. THREE POSSIBLE DATES FOR THIS EVENT INCLUDE, 15SEP2022, 10MAR2023, AND 15MAR2023. DATE CLARIFICATION HAS BEEN REQUESTED. THE PHYSICIAN REPORTED THAT BRONCHOSCOPIC GUIDANCE WAS USED DURING PLACEMENT. IT WAS CONFIRMED THAT THE PROXIMAL END OF THE BLUE RHINO DILATOR WAS POSITIONED AT THE SINGLE POSITIONING MARK ON THE WHITE GUIDING CATHETER. DURING THE PROCEDURE, THE BLUE RHINO DILATOR ADVANCED BEYOND THE SAFETY RIDGE OF THE WHITE GUIDING CATHETER. THE WIRE GUIDE WAS NOT LEADING THE DILATOR AND GUIDING CATHETER ASSEMBLY AFTER THE BLUE RHINO ADVANCED OVER THE SAFETY RIDGE. IT WAS NOTED THAT ULTRASOUND WAS NOT USED TO EVALUATE THE PATIENT'S NECK PRIOR TO THE PROCEDURE.

  Patient problems: Upper Respiratory Tract Injury

  MAUDE report 16797445 ↗
• InjuryApr 24, 2023Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Upper Respiratory Tract Injury

  MAUDE report 16797354 ↗
• InjuryApr 24, 2023Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Upper Respiratory Tract Injury

  MAUDE report 16797143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193133. One submission often covers many models, so check the product and lot details in each record.

• Z-1779-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA
• Z-1427-2023 · Apr 7, 2023 · Open, Classified
  Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FL
• Z-1428-2023 · Apr 7, 2023 · Open, Classified
  Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-