Shiley 6DCFNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884522006613), received between Apr 16, 2020 and Apr 16, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (1 report).

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 23, 2026Open, Classified

   Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

   Z-2653-2026 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2020Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE WAS PROTRUDING AND IRRITATING THE TRACHEA. THE DEVICE WAS TAKEN OUT AFTER BLOOD WAS FOUND DUE TO SUCTIONING AND PATIENT WAS BREATHING OUT THROUGH THE STOMA DURING THAT TIME. THE TUBE OF THE DEVICE WAS CRACKED AND THE PATIENT COULD NOT BE SUCTION THROUGH STOMA. THE DEVICE WILL BE REPLACED THE FOLLOWING MORNING ONCE A REPLACEMENT IS RECEIVE FROM THE DISTRIBUTOR. PATIENT WAS CURRENTLY STABLE AND UNHARMED.

  Patient problems: Extubate

  MAUDE report 9970723 ↗

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-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-1472-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1477-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• 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-1473-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, C
• 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-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-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-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-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-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-1491-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Inten
• Z-1471-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA

…and 8 more.