Dale 240 BlueRecalls & reported problems
Dale Medical Products, Inc. · Dale Tracheostomy Tube Holder, 1" wide, fits up to 19.5" neck. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817612020667), received between Apr 5, 2022 and Sep 1, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Most reported problems
Device problems
- Break2
- Material Split, Cut or Torn1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2022No Apparent Adverse Event; No Apparent Adverse Event
"TRACH TUBE HOLDER FASTENER BROKE OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334637 ↗MalfunctionApr 5, 2022Material Split, Cut or Torn
WHEN CHANGING TRACH TIES, I WENT TO TIGHTEN THE TIES AND THE WHITE FASTENER RIPPED RIGHT OFF.
Patient problems: Insufficient Information
MAUDE report 14013581 ↗MalfunctionApr 5, 2022Break
"ADOLESCENT PATIENT WITH A TRACHEOSTOMY TUBE AND MECHANICAL VENTILATION. VELCRO PART OF THE TRACH HOLDER/STRAP WAS FOUND TO BE COMPLETELY DETACHED/BROKEN OFF FROM THE SOFT PART OF THE STRAP THAT ENCIRCLES THE NECK. THERE WAS NO ACTUAL PATIENT HARM. TRACH TUBE DID NOT BECOME DISLODGED BECAUSE THE VENT HOLDER (WHICH IS ALSO SECURED WITH VELCRO) WAS ATTACHED. TRACH HOLDER/STRAP WAS REPLACED UPON DISCOVERY OF BREAKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14013385 ↗MalfunctionApr 5, 2022Break
"ADOLESCENT PATIENT WITH TRACHEOSTOMY TUBE AND MECHANICAL VENTILATION. WHILE DOING TRACH CARE, VELCRO PART OF THE TRACH. HOLDER / STRAP BROKE OFF COMPLETELY FROM THE SOFT PART OF THE STRAP THAT ENCIRCLES THE NECK. STAFF MEMBER CHANGED TO A NEW HOLDER AND ENSURED IT WAS SECURE. THIRTY MINUTES LATER, THE VELCRO PART BROKE AGAIN, AND HOLDER WAS REPLACED AGAIN. NO ACTUAL PATIENT HARM BUT POTENTIAL FOR TRACH TUBE DISLODGEMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14013346 ↗
Other Device, Fixation, Tracheal Tube devices
- AnchorFast 9799Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 death49 reports
- AnchorFast SlimFit 9787Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall4 reports
- AnchorFast Guard 9800Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall4 reports
- AnchorFast Guard Select 9700Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 report
- Medline DYNJMBRC2Medline Industries, Inc. · DEVICE, FIXATION, TRACHEAL TUBE1 recall1 report
- Medline DYNJMBRC4BMedline Industries, Inc. · DEVICE, FIXATION, TRACHEAL TUBE1 recall0 reports
- AnchorFast 9799Hollister Incorporated · DEVICE, FIXATION, TRACHEAL TUBE21 reports
- HUDSON RCI IPN914324Teleflex Incorporated · DEVICE, FIXATION, TRACHEAL TUBE6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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