CAPRecalls & reported problems across all models
Burlington Medical, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CAP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 8 models of CAP by Burlington Medical, LLC in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2024 and Oct 30, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CAP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 11, 2026Open, Classified
Potential for attenuation degradation over time, decreasing the lifespan.
Z-1760-2026 · Root cause: Process change control · names 6 of these models · Recall details · FDA record ↗
Most reported CAP problems
Device problems
- Connection Problem1
- Disconnection1
Patient problems
- Insufficient Information1
- Unintended Extubation1
CAP models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CAP R8CAP-SM_MDShield, Protective, Personnel1 recall0 reports
- CAP R8CAP-LG_XLShield, Protective, Personnel1 recall0 reports
- CAP S8CAP-SM_MDShield, Protective, Personnel1 recall0 reports
- CAP S8CAP-LG_XLShield, Protective, Personnel1 recall0 reports
- CAP U8CAP-SM_MDShield, Protective, Personnel1 recall0 reports
- CAP U8CAP-LG_XLShield, Protective, Personnel1 recall0 reports
- CAP CAP8-U8CAP-LG_XLApron, Protective1 report
- CAP CAPL-ULCAP-LG_XLShield, Protective, Personnel1 report
Recent CAP adverse event reports
The 2 most recent reports across all models, 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 ↗MalfunctionJun 28, 2024Connection Problem; Connection Problem
ACCORDING TO THE REPORTER, THE CAP FOR THE TRACHEOSTOMY TUBE WAS NOT SECURING TO THE 15-MM CONNECTOR, EVEN AFTER A ONE-FOURTH TURN HAD BEEN COMPLETED, AND APPEARED LOOSE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 19639224 ↗
Other Burlington Medical, LLC products
- Thyroid Shield BAT3 models · 0 reports · 1 recall
- VEST48 models · 0 reports · 1 recall
- KILT BLOCKER12 models · 0 reports · 1 recall
- DHALF5 models · 0 reports · 1 recall
- LEG WRAP10 models · 0 reports · 1 recall
- KILT50 models · 0 reports · 1 recall
- SLEEVE15 models · 0 reports · 1 recall
- QVEST18 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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