Medline HCS7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 40080196769293), received between Jun 25, 2024 and Sep 29, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K042349); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Contamination; Device Emits Odor; Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938061 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component; Damaged Thread

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934140 ↗
• MalfunctionSep 29, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932753 ↗
• MalfunctionSep 25, 2026Corroded; Power Problem; Suction Failure

  It was reported that "will not turn on."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897515 ↗
• MalfunctionSep 24, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886487 ↗
• MalfunctionSep 24, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884324 ↗
• MalfunctionSep 23, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872941 ↗
• MalfunctionSep 23, 2026Suction Problem

  It was reported that the device turned on and experienced low suction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869291 ↗
• MalfunctionSep 23, 2026Increase in Pressure

  The report states, "Backpressure not allowing device to function properly even after removing entirety of patient interface."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867378 ↗
• MalfunctionSep 22, 2026Suction Problem

  It was reported that "LOW SUCTION AT HIGH SETTING, DOES NOT SUCTION OTHERWISE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858423 ↗
• MalfunctionSep 22, 2026Suction Problem

  This VMSR report summarizes 2 malfunction events that occurred during Q3 2023 (July 1, 2023 through September 30, 2023). The account reported that two HCS7000 suction aspirators exhibited a "No Vac25 Test" condition. The customer reported the issue on both devices; however, additional information regarding the failure mode, operating conditions, and device behavior was not provided. Multiple requests were made for further details, including video evidence and clarification of the reported condition. Prior to completion of the investigation, the customer requested closure of the complaint. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857080 ↗
• MalfunctionSep 22, 2026Corroded; Noise, Audible; Suction Failure

  It was reported that "the suction partis not suctioning. Making a loud noice."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856770 ↗
• MalfunctionSep 22, 2026Suction Problem

  The report states, "All 4 suction machines are experiencing low suction pressure along with a loud rattling noise coming from inside the machine."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852430 ↗
• MalfunctionAug 17, 2026Suction Problem

  It was reported that (b)(6) has a suction machine that no longer works.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275223 ↗
• MalfunctionJul 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068220 ↗
• MalfunctionJun 11, 2026Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE IS NOT TURNING ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472454 ↗
• MalfunctionMay 19, 2026Suction Problem

  PER REPORT, "ISSUE IS UNIT IS NOT POWERING ON AND CUSTOMER IS LOOKING FOR A REPLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215992 ↗
• MalfunctionJan 15, 2026Suction Failure

  ACCORDING TO THE FACILITY, "A RESIDENT WAS IN NEED OF EMERGENCY SUCTION AND WE PULLED THREE CANISTERS TO USE AND ALL THREE WOULD NOT SUCTION".

  Patient problems: Airway Obstruction; Discomfort; Dyspnea

  MAUDE report 24085273 ↗
• MalfunctionJan 15, 2026Suction Failure

  ACCORDING TO THE FACILITY, "A RESIDENT WAS IN NEED OF EMERGENCY SUCTION AND WE PULLED THREE CANISTERS TO USE AND ALL THREE WOULD NOT SUCTION".

  Patient problems: Airway Obstruction; Discomfort; Dyspnea

  MAUDE report 24080151 ↗
• MalfunctionJan 13, 2026Suction Failure

  ACCORDING TO THE FACILITY, "A RESIDENT WAS IN NEED OF EMERGENCY SUCTION AND WE PULLED THREE CANISTERS TO USE AND ALL THREE WOULD NOT SUCTION".

  Patient problems: Airway Obstruction; Discomfort; Dyspnea

  MAUDE report 24063327 ↗
• InjuryJun 25, 2024Pressure Problem; Pressure Problem

  PRESSURE LOST.

  Patient problems: Insufficient Information

  MAUDE report 19605475 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042349. One submission often covers many models, so check the product and lot details in each record.

• Z-2642-2014 · Aug 3, 2014 · Terminated
  Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respirator