CAP CAPL-ULCAP-LG_XLRecalls & reported problems
Burlington Medical, LLC · Cap - Standard Size with Drawstring Toggle Closure, .25mm Lead Size Large / Extra Large · Class 1
All models of CAP (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840331257588), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection1
Patient problems
- Unintended Extubation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Disconnection; Disconnection
ACCORDING TO THE REPORTER, DURING USE, THE CAP OF THE ENDOTRACHEAL TUBE KEPT POPPING OFF WHEN ON A PATIENT. THE TUBE WAS REPLACED AND WORKED.
Patient problems: Unintended Extubation
MAUDE report 20567715 ↗
Other Shield, Protective, Personnel devices
- SLEEVE R8SL3-MDBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- SLEEVE S8SL3-MDBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- CAP R8CAP-SM_MDBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- CAP S8CAP-LG_XLBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- SLEEVE U8SL3-XSBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- SLEEVE U8SL3-SMBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- SLEEVE R8SL3-XSBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 reports
- SLEEVE U8SL3-LGBurlington Medical, LLC · Shield, Protective, Personnel1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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