Blue Rhino G57686Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002576865), received between Jun 30, 2022 and Oct 27, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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-1779-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IN ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE; NO ADDITIONAL DEVICE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153434 ↗
• MalfunctionJun 30, 2022Deformation Due to Compressive Stress; Difficult to Advance; Material Too Soft/Flexible; Deformation Due to Compressive Stress; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. THIS REPORT CAPTURES ONE SPECIFIC EVENT, AS WELL AS OTHER UNKNOWN INSTANCES OF THIS FAILURE. THE USER NOTICED THAT THE DILATOR SEEMS "SOFTER AND LIGHTER IN COLOR". IT WAS ALSO STATED THAT IT APPEARED VERY SMOOTH AND IT QUICKLY "DOUBLE NODS" DURING DILATION, "ESPECIALLY IN YOUNGER PATIENTS WHO WERE GIVEN A TRACHEA CANNULA." THE PROCEDURES WERE COMPLETED WITHOUT COMPLICATIONS. AS REPORTED, THE PATIENTS 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 14875153 ↗

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-1780-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-
• 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-