MEDLINE HCSM70JRecalls & reported problems
Medline Industries, Inc. · OXIMETER, PULSE, FINGERTIP, LED, W/ CASE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medline fingertip pulse oximeter, a small clip-on device that measures oxygen level and pulse through the finger. The 33 reports filed since April 2026 mostly describe units that will not turn on at all, even with fresh batteries, or that light up without showing any numbers or reading. There are no deaths and no reported injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00197344065564), received between Apr 20, 2026 and Sep 29, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up4
- Unable to Obtain Readings3
- Excessive Heating2
- No Device Output2
- Electrical Shorting1
- Imprecise or Erratic Results1
- Intermittent Loss of Power1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Electrical Shorting
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938053 ↗MalfunctionSep 24, 2026Unable to Obtain Readings; Unexpected Shutdown
It was reported that BOTH OXIMETERS ARE DEFECTIVE. THEY ARE NOT FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884051 ↗MalfunctionJun 25, 2026Failure to Power Up
IT WAS REPORTED THAT THE DEVICE DOES NOT TURN ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627063 ↗MalfunctionJun 23, 2026Imprecise or Erratic Results
IT WAS REPORTED THAT THE DEVICE IS PRODUCING INCONSISTENT/INACCURATE READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25595347 ↗MalfunctionJun 19, 2026Power Problem
IT WAS REPORTED THAT THE PULSE OXIMETER WOULD NOT TURN ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565144 ↗MalfunctionJun 10, 2026Failure to Power Up
IT WAS REPORTED THAT THE DEVICE WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456607 ↗MalfunctionJun 4, 2026Overheating of Device; Intermittent Loss of Power
IT WAS REPORTED THAT THE DEVICE IS OVERHEATING AND TURNING ON/OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25394659 ↗MalfunctionJun 1, 2026Failure to Power Up
IT WAS REPORTED THAT THE UNIT WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349048 ↗MalfunctionMay 27, 2026Unable to Obtain Readings
PER REPORT, "THE ITEM WILL TURN OFF IN THE MIDDLE OF THE END USER USING THE ITEM. THE ACCOUNT IS REQUESTING A REPLACEMENT ON BEHALF OF THE END USER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306127 ↗MalfunctionMay 13, 2026Excessive Heating
IT WAS REPORTED THAT THE OXIMETER "IS NOT FUNCTIONING, AND THE BATTERIES BECOME EXCESSIVELY HOT AS SOON AS THEY ARE INSERTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162196 ↗MalfunctionMay 9, 2026No Device Output; Noise, Audible
IT WAS REPORTED THAT THE DEVICE POWERED ON BUT SUBSEQUENTLY EMITTED AN UNUSUAL NOISE AND THEN WENT ENTIRELY BLANK OR BLACK, FAILING TO TURN BACK ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133157 ↗MalfunctionMay 9, 2026Excessive Heating
IT WAS REPORTED THAT THE OXIMETER WAS EXTREMELY HOT AFTER TESTING IT WITH BATTERIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25132871 ↗MalfunctionMay 9, 2026No Device Output
IT WAS REPORTED ON 04/10 THAT THE DEVICE PULSATES BUT DOESN'T PROVIDE A READING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25132850 ↗MalfunctionMay 6, 2026Unable to Obtain Readings
PER REPORT, "CUSTOMER CALLED IN STATING THE OXIMETER IS NO LONGER READING. CUSTOMER REPLACED THE BATTERIES AND THE OXIMETER IS STILL NOT READING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095180 ↗MalfunctionApr 21, 2026Output Problem
PER THE REPORT, "MEDLINE FINGERTIP PULSE OXIMETER 1CT, EVEN CHANGING BATTERIES ITEM STILL DOESN'T WORK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939272 ↗MalfunctionApr 20, 2026Failure to Power Up
IT WAS REPORTED THAT THE FINGERTIP PULSE OXIMETER (HCSM70J) WAS "NOT WORKING EVEN AFTER CHANGING THE BATTERIES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927494 ↗
Other oximeter, infrared, sporting, aviation devices
- Medline HCSM70RMedline Industries, Inc. · oximeter, infrared, sporting, aviation4 reports
- Medline HCSM70TMedline Industries, Inc. · oximeter, infrared, sporting, aviation2 reports
- MightySat™ Fingertip Pulse Oximeter 9700Masimo Corporation · oximeter, infrared, sporting, aviation1 report
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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