MEDLINE HARH36RRecalls & reported problems

Medline Industries, Inc. · HARMONIC ACE+7 SHEARS 5MM X 36CM · Class U

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: 24
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10193489081329), received between Mar 13, 2025 and Sep 30, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K193563); 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. 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.

Recalls naming this device

May 7, 2024Open, Classified
Potential for an incomplete seal on the packaging tray.
Z-3095-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Electrical /Electronic Property Problem5
Break4
Detachment of Device or Device Component3
Failure to Fire3
Activation Failure2
Material Fragmentation2
Communication or Transmission Problem1
Connection Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions18
Foreign Body In Patient5
Burn(s)1
Insufficient Information1

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Material Separation; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952745 ↗
MalfunctionSep 30, 2026Unsealed Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952739 ↗
MalfunctionSep 30, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952652 ↗
MalfunctionSep 29, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937713 ↗
MalfunctionSep 28, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923419 ↗
MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923247 ↗
MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923224 ↗
MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902704 ↗
MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889900 ↗
MalfunctionSep 24, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889864 ↗
MalfunctionSep 23, 2026Communication or Transmission Problem
Patient problems: Insufficient Information
MAUDE report 50873621 ↗
MalfunctionMay 20, 2026Failure to Fire
IT WAS REPORTED THAT, HARMONIC SCALPELS NOT FIRING CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236649 ↗
MalfunctionMay 20, 2026Failure to Fire
IT WAS REPORTED THAT, THE HARMONIC SCALPEL WAS NOT FIRING CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236647 ↗
MalfunctionMay 20, 2026Failure to Fire
IT WAS REPORTED THAT, HARMONIC SCALPELS NOT FIRING CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236646 ↗
MalfunctionMay 20, 2026Mechanical Problem
IT WAS REPORTED THAT, HARMONIC SCALPELS, BLADE PRESSURE ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236645 ↗
MalfunctionMay 20, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT, HARMONIC SCALPELS STOPPED RECOGNIZING DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236643 ↗
MalfunctionMay 16, 2026Thermal Decomposition of Device; Overheating of Device
IT WAS REPORTED THAT, 36HARMONIC ARE MELTING INSIDE OF PATIENTS. TWO OF THEM MELTED TODAY BACK TO BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194833 ↗
MalfunctionMay 16, 2026Material Fragmentation; Peeled/Delaminated; Excessive Heating
IT WAS REPORTED THAT, PER STAFF IN THE ROOM, A PIECE OF PLASTIC BROKE WAS RETRIEVED. WHILE INACTIVE THE BLADE STARTED TO PEEL. THE INSTRUMENT WAS ENTIRELY TOO HOT ENTIRE SHAFT WAS TOO HOT TO EVEN TOUCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194832 ↗
MalfunctionMay 3, 2026Break
ACCORDING TO THE CUSTOMER, DEVICE FELL APART UPON OPENING THE PACKAGE, AND WAS NOT USED IN THE CASE AS IT COMPLETELY FELL APART. BROKE OPEN WITH PIECES EVERYWHERE RIGHT OUT OF THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063885 ↗
MalfunctionFeb 24, 2026Connection Problem
ACCORDING TO THE CUSTOMER, DURING A "LAPAROSCOPIC HYSTERECTOMY" PROCEDURE ON (B)(6) 2026 THE HARMONIC SHOWED A "MALFUNCTION" AND THE END "FELL OFF INTO ABDOMINAL CAVITY" WHILE RUNNING A "TEST".
Patient problems: Foreign Body In Patient
MAUDE report 24433303 ↗
MalfunctionDec 5, 2025Break; Break
ACCORDING TO THE FACILITY, ON (B)(6)2025, WHILE THE DOCTOR WAS USING THE INSTRUMENT DURING A LAPAROSCOPIC CASE, "THE SCRUB NURSE QUICKLY NOTED THE BLADE HAD FALLEN/BROKEN OFF THE INSTRUMENT AND LANDED IN THE ABDOMEN. SURGEON WAS ABLE TO RETRIEVE THE PIECE THROUGH A TROCAR SITE WITH A LAPAROSCOPIC GRASPING TOOL."
Patient problems: Foreign Body In Patient
MAUDE report 23729858 ↗
MalfunctionNov 24, 2025Break; Break
ACCORDING TO THE CUSTOMER, DURING A "LAPAROSCOPIC PROCEDURE, THE WHITE PIECE INSIDE THE JAWS OF THE REPROCESSED HARMONIC CAME OFF INSIDE THE PATIENT'S ABDOMEN."
Patient problems: Foreign Body In Patient
MAUDE report 23639870 ↗
MalfunctionAug 6, 2025Material Fragmentation; Material Fragmentation
THE TIP OF THE DEVICE FELL APART IN THE ABDOMEN DURING USE.
Patient problems: Foreign Body In Patient
MAUDE report 22727249 ↗
InjuryMar 13, 2025Break; Break
ACCORDING TO THE CUSTOMER, THE HARMONIC SHEARS "BROKE AND BURNT UP INSIDE PATIENT".
Patient problems: Burn(s); Foreign Body In Patient
MAUDE report 21594634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193563. One submission often covers many models, so check the product and lot details in each record.

Z-0120-2024 · Aug 3, 2023 · Open, Classified
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.

Device details

UDI-DI	`10193489081329`
Brand	MEDLINE
Model	HARH36R
Company	Medline Industries, Inc.
Product code	NLQ · Single-use reprocessed ultrasonic surgical instruments
Class	Class U
FDA submission	K193563
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Laparoscopic blunt dissector

A sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). This is a single-use device.

Other Single-use reprocessed ultrasonic surgical instruments devices

N/A
Stryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed
1 recall94 reports
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Stryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed
1 recall24 reports
N/A
Stryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed
67 reports
Medline HARH45R
Medline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments
1 recall2 reports
N/A
Stryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed
1 death31 reports
N/A HAR1136
Stryker Sustainability Solutions, Inc. · Single-use reprocessed ultrasonic surgical instruments
24 reports
Medline HAR36MR
Medline Industries, Inc. · Scalpel, ultrasonic, reprocessed
16 reports
Ace + 7 HARH36R
Sterilmed, Inc. · Scalpel, ultrasonic, reprocessed
8 reports

All Single-use reprocessed ultrasonic surgical instruments 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 · 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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