DeRoyal 71-8004Recalls & reported problems
Deroyal Industries, Inc. · SUCTION CANISTER, 2500cc, RIGID · Class 2
Data updated Oct 18, 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 00749756354974), received between Jun 18, 2025 and Jun 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Suction Failure” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Suction Failure1
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.
MalfunctionJun 18, 2025Suction Failure; Suction Failure
A USER FACILITY REPORTED, "THIS OCCURRED AT LEAST 2 TIMES WITH SUCTIONS ANESTHESIA PROVIDERS WERE USING. TO MY KNOWLEDGE THE CORRECT PORTS ARE BEING USED. WE DO NOT USE ANY SOLIDIFIER UNTIL THE PROCEDURE IS COMPLETED (TO ENSURE ACCURATE TRACKING OF FLUID OUTPUT). DURING THESE 2 INSTANCES THE SUCTION HAD BEEN WORKING BUT STOPPED MID PROCEDURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22285326 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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