DeRoyal 71-6510Recalls & reported problems
Deroyal Industries, Inc. · SUCTION CANISTER, 1000cc,SAFELINER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00749756665728), received between Jun 1, 2018 and Dec 23, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Fluid/Blood Leak3
- Suction Problem3
- Suction Failure1
Patient problems
- No Patient Involvement3
- Aspiration/Inhalation1
- No Clinical Signs, Symptoms or Conditions1
- Vomiting1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2024Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, "THE DEROYAL CANNISTER LID WAS FOUND TO BE DEFORMED CAUSING A LEAK IN THE SUCTION SET UP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21003752 ↗InjuryAug 7, 2024Suction Failure; Suction Failure
CANISTER DID NOT MAINTAIN SUCTION DURING INTERMITTENT SUCTION USE. REPORT OF PATIENT VOMITING.
Patient problems: Aspiration/Inhalation; Vomiting
MAUDE report 19929648 ↗MalfunctionJun 1, 2018Fluid/Blood Leak; Leak/Splash; Suction Problem; Fluid/Blood Leak; Leak/Splash; Suction Problem
THE SUCTION CANISTER DID NOT WORK PROPERLY. FLUID BACK FILLED INTO THE TUBING LINE DURING SURGERY IN THE OR.
Patient problems: No Patient Involvement
MAUDE report 7561359 ↗MalfunctionJun 1, 2018Fluid/Blood Leak; Leak/Splash; Suction Problem; Fluid/Blood Leak; Leak/Splash; Suction Problem
DURING USE, THE PRODUCT BACK FILLED INTO THE TUBING LINE.
Patient problems: No Patient Involvement
MAUDE report 7561354 ↗MalfunctionJun 1, 2018Fluid/Blood Leak; Leak/Splash; Suction Problem; Fluid/Blood Leak; Leak/Splash; Suction Problem
DURING USE, THE PRODUCT BACK FILLED INTO THE TUBING LINE.
Patient problems: No Patient Involvement
MAUDE report 7561353 ↗
Other BOTTLE, COLLECTION, VACUUM devices
- OASIS 3600-100Atrium Medical Corporation · Bottle, Collection, Vacuum3 recalls1 death175 reports
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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