MEDLINE EBSI1307BRecalls & reported problems
Medline Industries, Inc. · PEDS LINE CHNG TRAY -SP GLUE ATTACHED · Class 1
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 10653160360599), received between Sep 24, 2026 and Sep 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Fluid/Blood Leak; Premature Activation
It was reported that the secureportiv that is piggybacked on these kits are leaking and causing the glue to harden prior to use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886522 ↗
Other Dressing change tray devices
- MEDLINE EBSI1498Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT8670ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion Medical Products Corp DT22065Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT21275Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1382Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DM1035Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion DT18700Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1464Medline Industries, Inc. · Dressing change tray2 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page