Medline OR530Recalls & reported problems
Medline Industries, Inc. · LINER,SEMI-RIGID,3000CC,50EA/CS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 40884389968117), received between Jan 31, 2025 and Sep 17, 2026 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (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
- Fitting Problem1
- Use of Device Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809594 ↗DeathJan 31, 2025Use of Device Problem; Use of Device Problem
A NOTIFICATION WAS RECEIVED FROM MEDLINE FRANCE REGARDING AN ADVERSE EVENT ASSOCIATED WITH OR530. IT WAS REPORTED BY THE USER FACILITY THAT DURING A MEDICAL EMERGENCY, SUCTION OF THE AIRWAY WAS REQUIRED IN ORDER TO INTUBATE THE PATIENT, HOWEVER THE WALLED SUCTION UNIT WAS NOT SET UP READY TO USE AND WHEN SET UP, IT DID NOT WORK CORRECTLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21286253 ↗
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- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- EXPRESS 4000-100NAtrium Medical Corporation · Bottle, Collection, Vacuum2 recalls30 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 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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