Medline HCS7001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10193489036381), received between Mar 6, 2025 and Sep 30, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (13 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Decrease in Suction

  It was reported that "the unit suction is not strong."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952376 ↗
• MalfunctionSep 30, 2026Decrease in Suction; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951134 ↗
• MalfunctionSep 30, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948724 ↗
• MalfunctionSep 30, 2026Suction Failure

  Broken suction machine. Not suctioning.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946311 ↗
• MalfunctionSep 30, 2026Decrease in Suction; Temperature Problem; Suction Failure

  This VMSR report summarizes 5 malfunction events that occurred during Q3 2023 (July 1, 2023, through September 30, 2023). The account reported that HCS7001 portable suction aspirators continued to lose suction and heat up during use. The reported issue involved devices associated with serial numbers (b)(6). Replacement units were requested, and the affected devices were available for return and evaluation. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945250 ↗
• MalfunctionSep 29, 2026Decrease in Suction; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938686 ↗
• MalfunctionSep 29, 2026Decrease in Suction; Noise, Audible

  It was reported that "low pressure and loud".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933045 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component; Suction Failure

  This VMSR report summarizes 2 malfunction events that occurred during Q2 2023 ((b)(6) , 2023). The account reported that two suction machines failed to provide suction during use. The customer stated that upon powering on the devices, the suction gauge did not move and no suction was generated. The issue was reported for two units received under separate orders, and the affected devices were returned for evaluation. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931394 ↗
• MalfunctionSep 25, 2026Decrease in Suction

  It was reported that "LOW PRESSURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900411 ↗
• MalfunctionSep 24, 2026Suction Failure

  It was reported that "ITEM IS NOT SUCTIONING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883977 ↗
• MalfunctionSep 23, 2026Decrease in Suction; Mechanical Problem; Noise, Audible

  This VMSR summary report covers malfunction events that occurred in Q4 of 2024. The report summarizes 3 malfunction events involving Aspirators & Air Com (HCS7001). Customer reported that ¿LOW PRESSURE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871770 ↗
• MalfunctionSep 23, 2026Decrease in Suction

  It was reported that after the products were "returned from the field and went through the cleaning procedure" they developed "poor and intermittent suctioning".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868467 ↗
• MalfunctionSep 22, 2026Decrease in Suction; Mechanical Problem; Suction Failure

  It was reported that "When we arrived at the client's home to set it up for them and turned it on, we quickly noticed it wasn't sucking at all and then noticed the gage was not rising either. I've detached and reattached all tubes in hopes that would make a difference but even with no tube connections it should still have suction."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850007 ↗
• MalfunctionSep 18, 2026Decrease in Suction; Noise, Audible

  It was reported that "THE MACHINE SOUNDS LOUDER THAN NORMAL AND DOES NOT HAVE ENOUGH SUCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818985 ↗
• MalfunctionJun 19, 2026Decrease in Suction

  IT WAS REPORTED THAT THE SUCTION IS DECREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566503 ↗
• MalfunctionMay 24, 2026Suction Problem

  PER THE REPORT, THE ITEM DOES NOT HAVE SUFFICIENT SUCTIONING POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267401 ↗
• MalfunctionMay 21, 2026Decrease in Pressure

  IT'S REPORTED THAT PER ZENDESK TICKET # (B)(4) - DOES NOT APPEAR TO BE WORKING PROPERLY. WE ATTEMPTED TO USE IT TO SUCTION BASIC WATER, AND THE PRESSURE WAS EXTREMELY WEAK, IF PRESENT AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250512 ↗
• MalfunctionMay 5, 2026Decrease in Suction; Decrease in Pressure

  PER CUSTOMER CALL, "THE ASPIRATOR HAS LOW SUCTION AND VERY LOW PRESSURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085705 ↗
• InjuryAug 20, 2025Infusion or Flow Problem; Suction Failure; Infusion or Flow Problem; Suction Failure

  ACCORDING TO THE CUSTOMER, THE DEVICE STOPPED WORKING ON (B)(6) 2025. THE CUSTOMER SAID THAT THE ASPIRATOR WOULD NOT "ACCELERATE PAST ZERO" AND THAT HER SON IS AT RISK FOR ASPIRATION OF FLUIDS DUE TO BRAIN INJURY. THE CUSTOMER REPORTED HER SON WAS ADMITTED TO THE ICU AND PUT ON A VENTILATOR ON (B)(6) 2025 BUT IS NOW "OFF THE VENT" AND DOING BREATHING TRIALS WITH SUPPLEMENTAL OXYGEN.

  Patient problems: Insufficient Information

  MAUDE report 22849558 ↗
• MalfunctionMar 6, 2025Suction Problem; Suction Problem

  NOT PROVIDING ADEQUATE SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536498 ↗