M3 GoldRecalls & reported problems across all models
Gyrus ACMI, LLC · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one M3 Gold model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 5 models of M3 Gold by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2020 and Aug 26, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (13 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
M3 Gold recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 24, 2026Open, Classified
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Z-3300-2026 · Root cause: Process control · Recall details · FDA record ↗
- Aug 24, 2026Open, Classified
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Z-3299-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported M3 Gold problems
Device problems
- Sharp Edges13
- Break8
- Thermal Decomposition of Device5
- Peeled/Delaminated2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Degraded1
- Dent in Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information1
- No Patient Involvement1
M3 Gold models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M3 Gold M3-30AELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- M3 Gold M3-70AELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall0 reports
- M3 Gold REXM3-30AHysteroscope (And Accessories)14 reports
- M3 Gold M3-12AELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL4 reports
- M3 GOLD M3-0AELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 report
Recent M3 Gold adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456819 ↗MalfunctionAug 18, 2026Sharp Edges
The customer reported sharp edge on the lens part during an inspection for use involving an Olympus Hysteroscope (And Accessories). There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301613 ↗MalfunctionAug 5, 2026Sharp Edges
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143849 ↗MalfunctionApr 6, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FOROBLIQUE TELESCOPE HAD CRACKED OBJECTIVE COVER GLASS AND BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792894 ↗MalfunctionMar 31, 2026Break; Environmental Particulates
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE HYSTEROSCOPE AND ACCESSORIES EXHIBIT CHIPPED OBJECTIVE LENS AND BROKEN COVER GLASS ALSO DUST PARTICLES WERE FOUND UNDER THE EYEPIECE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747503 ↗MalfunctionMar 6, 2026Sharp Edges
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE (AND ACCESSORIES) EXHIBITED DISTAL END DENTS, SHARP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533481 ↗MalfunctionFeb 10, 2026Degraded
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306495 ↗MalfunctionJan 28, 2026Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202230 ↗MalfunctionNov 19, 2025Sharp Edges; Sharp Edges
IT WAS REPORTED THAT THE DISTAL TIP OF THE RIGID SCOPE WAS SHARP. THE ISSUE WAS FOUND DURING RECEIPT OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23596119 ↗MalfunctionOct 21, 2024Break; Break
WHILE EVALUATING AN OLYMPUS M3-GOLD AUTOCLAVABLE TELESCOPE, IT WAS DISCOVERED THAT THE OUTER TUBE WAS DAMAGED BEYOND REPAIR AND THE IMAGE BUNDLE HAD BROKEN FIBERS PRESENT. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493429 ↗MalfunctionOct 21, 2024Thermal Decomposition of Device; Peeled/Delaminated; Thermal Decomposition of Device; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE DISTAL TIP OF THE REPAIR SCOPE WAS BURNED AND HAD A PEELING METAL PIECE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493280 ↗MalfunctionSep 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE REPAIR SCOPE AUTOCLAVABLE EXHIBITED A BURNT TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20160549 ↗MalfunctionSep 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID ENDOSCOPE TELESCOPE'S DISTAL TIP WAS BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157096 ↗MalfunctionJul 26, 2024Sharp Edges; Sharp Edges
IT WAS REPORTED THE TELESCOPE HAD A BURNT TIP, CAUSING A SHARP EDGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT NOR PROCEDURAL INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19844605 ↗MalfunctionJul 26, 2024Material Separation; Sharp Edges; Material Separation; Sharp Edges
IT WAS REPORTED THE HYSTEROSCOPE HAD BURNT TIP AND SHARP EDGE CAUSING SEPARATION ON THE LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838120 ↗
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- PK TECHNOLOGY10 models · 24 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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