DeRoyal PHESL-1000BRecalls & reported problems
Deroyal Industries, Inc. · SafeLiner Suction Canister 1000cc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00749756377041), received between Aug 7, 2024 and Dec 6, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (3 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Feb 9, 2023Open, Classified
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
Z-1283-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Suction Problem3
- Collapse1
- Decrease in Suction1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2024Suction Problem; Suction Problem
A USER FACILITY REPORTED, "THE DEROYAL SUCTION LINERS WERE INITIALLY UNABLE TO SUPPORT INTERMITTENT SUCTION DUE TO AN IMPROPER SEAL WITH THE SUCTION REGULATORS IN THE DEROYAL CANISTERS, THOUGH CONTINUOUS SUCTION WAS FUNCTIONAL. BIOMED FIRST ASSESSED, SUSPECTING A WALL LEAK, BUT PLANT OPERATIONS CONFIRMED NO WALL ISSUE. THEY FOUND THAT PROPERLY SEALING THE LINER TOP TO THE CANISTER ALLOWED INTERMITTENT SUCTION TO WORK. MULTIPLE TROUBLESHOOTING ATTEMPTS INCLUDED CHANGING OUT SUCTION MACHINES, PLASTIC CANISTERS, LINERS, TOPS, AND TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20866926 ↗MalfunctionOct 29, 2024Collapse; Collapse
A USER FACILITY REPORTED, "CANISTER ARE USED BY ANESTHESIA FOR SUCTION FOR [PATIOENT CARE. CANISTERS ARE COLLAPSING IN THE PATIENT ROOM. DELAYS CAUSED BY NEED TO CHANGE THE CANISTER DURING PROCEDURES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559207 ↗MalfunctionAug 7, 2024Suction Problem; Suction Problem
THEY ARE HAVING ISSUES WITH GETTING ADEQUATE SUCTION WITH SOME OF THEIR LINERS/CANISTERS. THEY HAD SOME OLD REGULATORS AND IDENTIFIED THAT AS PART OF THE PROBLEM. BUT STILL HAVING ISSUES W/ SOME OF THE NEW REGULATORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928891 ↗MalfunctionAug 7, 2024Decrease in Suction; Suction Problem; Decrease in Suction; Suction Problem
NURSE COULDN'T GET GOOD STRONG SUCTION WITH LINER ONLY VERY LOW PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928709 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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