Shiley 6FENRecalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 60884522007028), received between Apr 22, 2017 and Jul 15, 2026 — classified as 19 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (55 reports).

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

23 other recalls cover devices cleared under the same FDA submission (K962173); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 15, 2026Open, Classified

   Due to customer complaint regarding incorrect display box labeling.

   Z-2261-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Use of Device Problem

  Patient problems: Unintended Extubation

  MAUDE report 25825412 ↗
• MalfunctionJul 13, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804194 ↗
• MalfunctionJun 2, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE TRACH TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364892 ↗
• MalfunctionApr 28, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A TRACH CANNULA, THE CANNULA WAS DIFFICULT TO TURN/ADJUST. A REPLACEMENT TRACH CANNULA WAS OPENED AND USED FOR THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 25023447 ↗
• MalfunctionApr 3, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776214 ↗
• MalfunctionApr 1, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760801 ↗
• MalfunctionApr 1, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760780 ↗
• MalfunctionApr 1, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760692 ↗
• MalfunctionApr 1, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760678 ↗
• MalfunctionApr 1, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760655 ↗
• MalfunctionApr 1, 2026Component Missing; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760635 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376181 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376177 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376170 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376165 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376162 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376156 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376148 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376136 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE NINE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376127 ↗
• MalfunctionSep 9, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF WAS REACCUMULATING AIR WHILE PLUGGED DESPITE CUFF BEING DEFLATED. THE TUBE WAS REMOVED ON THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 23001118 ↗
• MalfunctionAug 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S PILOT VALVE MALFUNCTIONED CAUSED AN AIR LEAK ON THE FIRST DAY OF PATIENT USED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22805931 ↗
• MalfunctionAug 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE PILOT BALLOON OF THE TRACHEOSTOMY TUBE DID NOT INFLATE. THE PHYSICIAN ATTEMPTED TO INFLATE THREE TIMES WITHOUT SUCCESS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22745762 ↗
• InjuryJan 10, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF FENESTRATED TRACHEOSTOMY CANNULA'S CUFF DID NOT INFLATE, CAUSING DISCOMFORT TO THE PATIENT WITH COUGH AND SHORTNESS OF BREATH, EVEN IF THE BARONET WAS ALWAYS INFLATED. THE TRACH WAS REPLACED.

  Patient problems: Cough; Dyspnea; Unintended Extubation

  MAUDE report 21132289 ↗
• MalfunctionNov 7, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TRACHEOSTOMY TUBE'S CUFF HAD A RAPID AIR LEAK RIGHT AFTER INTUBATION REPLACED THE SECOND AND THIRD TIMES AND HAD THE SAME ISSUE. A FOURTH TUBE WORKED REPLACING THOSE 3 TUBES.

  Patient problems: Unintended Extubation

  MAUDE report 20634859 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962173. One submission often covers many models, so check the product and lot details in each record.

• Z-2174-2012 · Jul 18, 2012 · Terminated
  Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product
• Z-1488-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1467-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1462-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1476-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• Z-1480-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1469-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for byp
• Z-1489-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1464-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1465-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended
• Z-1470-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1468-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1490-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1466-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1479-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper

…and 8 more.