DeRoyal PHESL-1500BRecalls & reported problems

Deroyal Industries, Inc. · SafeLiner Suction Canister 1500cc · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 10
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00749756377058), received between Dec 23, 2024 and Aug 12, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Leak/Splash6
Suction Problem3
Fluid/Blood Leak2
Burst Container or Vessel1
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 12, 2025Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component
A USER FACILITY REPORTED THAT THEY HAD "46 LIDS (1500CC) THAT HAVE ADHESIVE ISSUES AGAIN THAT ARE POPPING OPEN DURING SURGERY AND LOOSING SUCTION.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786247 ↗
MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, THERE HAVE BEEN MULTIPLE REPORTS OF THE SUCTION CANISTERS NOT SEALING AT THE TOP. IT DOES NOT CAUSE A SUCTION PROBLEM, YET WHEN THE STAFF PULL THE SUCTION CANISTER FROM THE MACHINE, THE LID POPS OFF AND EXPOSES THE FLUID. THIS IS AN INFECTION CONTROL RISK TO OUR STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054059 ↗
MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, THERE HAVE BEEN MULTIPLE REPORTS OF THE SUCTION CANISTERS NOT SEALING AT THE TOP. IT DOES NOT CAUSE A SUCTION PROBLEM, YET WHEN THE STAFF PULL THE SUCTION CANISTER FROM THE MACHINE, THE LID POPS OFF AND EXPOSES THE FLUID. THIS IS AN INFECTION CONTROL RISK TO OUR STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054045 ↗
MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, THERE HAVE BEEN MULTIPLE REPORTS OF THE SUCTION CANISTERS NOT SEALING AT THE TOP. IT DOES NOT CAUSE A SUCTION PROBLEM, YET WHEN THE STAFF PULL THE SUCTION CANISTER FROM THE MACHINE, THE LID POPS OFF AND EXPOSES THE FLUID. THIS IS AN INFECTION CONTROL RISK TO OUR STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054044 ↗
MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, THERE HAVE BEEN MULTIPLE REPORTS OF THE SUCTION CANISTERS NOT SEALING AT THE TOP. IT DOES NOT CAUSE A SUCTION PROBLEM, YET WHEN THE STAFF PULL THE SUCTION CANISTER FROM THE MACHINE, THE LID POPS OFF AND EXPOSES THE FLUID. THIS IS AN INFECTION CONTROL RISK TO OUR STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054042 ↗
MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, THERE HAVE BEEN MULTIPLE REPORTS OF THE SUCTION CANISTERS NOT SEALING AT THE TOP. IT DOES NOT CAUSE A SUCTION PROBLEM, YET WHEN THE STAFF PULL THE SUCTION CANISTER FROM THE MACHINE, THE LID POPS OFF AND EXPOSES THE FLUID. THIS IS AN INFECTION CONTROL RISK TO OUR STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054041 ↗
MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, THERE HAVE BEEN MULTIPLE REPORTS OF THE SUCTION CANISTERS NOT SEALING AT THE TOP. IT DOES NOT CAUSE A SUCTION PROBLEM, YET WHEN THE STAFF PULL THE SUCTION CANISTER FROM THE MACHINE, THE LID POPS OFF AND EXPOSES THE FLUID. THIS IS AN INFECTION CONTROL RISK TO OUR STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054040 ↗
MalfunctionApr 22, 2025Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem
A USER FACILITY REPORTED, "WE ARE HAVING DIFFICULTY WITH CANISTER LINER CONTENTS GETTING INTO THE PLASTIC SECTION OF THE SUCTION HEAD. NURSING LEADERSHIP EXPERIMENTED WITH WATER AND DETERMINED THAT THE VALUE TO KEEP FLUID FROM LEAKING OUT OF THE LINER INTO THE CANISTER AND SUCTION HEAD IS NOT WORKING THUS LEADING TO URINE AND OTHER FLUIDS CONTAMINATING THE SUCTION HEAD AND NEEDING TO BE SENT TO STERILE PROCESSING FOR CLEANING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880692 ↗
MalfunctionApr 22, 2025Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem
A USER FACILITY REPORTED, "WE ARE HAVING DIFFICULTY WITH CANISTER LINER CONTENTS GETTING INTO THE PLASTIC SECTION OF THE SUCTION HEAD. NURSING LEADERSHIP EXPERIMENTED WITH WATER AND DETERMINED THAT THE VALUE TO KEEP FLUID FROM LEAKING OUT OF THE LINER INTO THE CANISTER AND SUCTION HEAD IS NOT WORKING THUS LEADING TO URINE AND OTHER FLUIDS CONTAMINATING THE SUCTION HEAD AND NEEDING TO BE SENT TO STERILE PROCESSING FOR CLEANING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880691 ↗
MalfunctionDec 23, 2024Burst Container or Vessel; Burst Container or Vessel
A USER FACILITY REPORTED THAT A SAFE LINER CANISTER BURST AND THE CONTENTS WENT EVERYWHERE IN THE OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21003798 ↗

Device details

UDI-DI	`00749756377058`
Brand	DeRoyal
Model	PHESL-1500B
Company	Deroyal Industries, Inc.
Product code	KDQ · BOTTLE, COLLECTION, VACUUM
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 14, 2023

Device type (GMDN): Suction system canister liner

A device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.

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OCEAN 2002-000
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EXPRESS 16400
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EXPRESS 4000-100N
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OCEAN 2002-400
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Medline DYNDSCL1500
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PNEUMOSTAT 16100
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All BOTTLE, COLLECTION, VACUUM devices →

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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