INSPIRARecalls & reported problems across all models
Hoya Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one INSPIRA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of INSPIRA by Hoya Corporation in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2023 and May 1, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Data Problem” (8 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
INSPIRA 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.
- Jul 16, 2025Open, Classified
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
Z-2329-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jan 29, 2025Open, Classified
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Z-1238-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported INSPIRA problems
Device problems
- Data Problem8
- Erratic or Intermittent Display7
- Poor Quality Image5
- Patient Data Problem4
- Unintended Movement4
- No Display/Image2
- Optical Obstruction2
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
INSPIRA models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INSPIRA EPK-i8020cEndoscope, accessories, image post-processing for color enhancement2 recalls24 reports
- INSPIRA EPK-i8020cBronchoscope (Flexible Or Rigid)3 reports
- INSPIRA EPK-i8020cEndoscope, accessories, image post-processing for color enhancement1 report
Recent INSPIRA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Sparking
ON 17-APR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN NORTH CAROLINA, UNITED STATES. A LOUD POPPING SOUND WAS HEARD FROM THE PROCESSOR IN THE ENDOSCOPY ROOM, AND SPARKS WERE REPORTED TO HAVE SHOT OUT FROM THE SIDE OF THE PROCESSOR. THE PROCESSOR IN QUESTION WAS REPLACED WITH AN ALTERNATIVE PROCESSOR. THIS EVENT DID NOT OCCUR DURING AN ENDOSCOPIC PROCEDURE. THERE WAS NO PATIENT HARM OR PROCEDURE DELAY RESULTING FROM THIS MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY. HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055055 ↗MalfunctionNov 14, 2025Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23551354 ↗MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
ON 14-SEP-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER F0158Z0062 IN SPAIN WITHIN THE EMEA REGION. THROUGH A GOOD FAITH EFFORT (GFE) CONDUCTED ON 15-OCT-2025, IT WAS CONFIRMED THAT THE INSPECTION RELATED TO THIS EVENT HAD NOT BEEN COMPLETED AT THE TIME OF THE INITIAL REPORT. WHEN USED FOR BLEEDING CASES, THE ENDOSCOPIC IMAGE DISPLAYED BY THE PROCESSOR APPEARED STRONGLY REDDISH. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412835 ↗MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
ON 03-OCT-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN SPAIN WITHIN THE EMEA REGION. WHEN USED FOR BLEEDING CASES, THE ENDOSCOPIC IMAGE DISPLAYED BY THE PROCESSOR APPEARED STRONGLY REDDISH. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412014 ↗MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
ON (B)(6) 2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN SPAIN WITHIN THE EMEA REGION. WHEN USED FOR BLEEDING CASES, THE ENDOSCOPIC IMAGE DISPLAYED BY THE PROCESSOR APPEARED STRONGLY REDDISH. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411961 ↗MalfunctionJul 3, 2025Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22391934 ↗MalfunctionJun 17, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22216898 ↗MalfunctionMay 28, 2025Poor Quality Image; Poor Quality Image
ON 13-MAY-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN AUSTRALIA WITHIN THE APAC REGION. DURING THE ENDOSCOPIC PROCEDURE, THE ENDOSCOPIC IMAGE TURNED REDDISH AND THEN BECAME DARK. AFTER THE IMAGE DARKENED, THE LIGHT LIMIT MODE OF THE PROCESSOR WAS ENABLED. AT THAT POINT, THE ENDOSCOPE HAD ALREADY REACHED THE ILEOCECAL REGION, MAKING IT DIFFICULT TO CLEAN THE DISTAL END WHILE IT WAS STILL INSIDE THE BODY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095596 ↗MalfunctionMay 14, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22015971 ↗MalfunctionFeb 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21393141 ↗MalfunctionFeb 5, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309750 ↗MalfunctionJan 28, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249383 ↗MalfunctionDec 25, 2024Data Problem; Data Problem
ERROR IN THE DOCUMENTATION! IF NO NEW PATIENT WAS SELECTED FROM THE WORKLIST BEFORE A NEW EXAMINATION, ALL NEWLY TAKEN PHOTOS ARE NOW AUTOMATICALLY ASSIGNED TO THE LAST SELECTED PATIENT, EVEN THOUGH THIS CASE WAS PROPERLY COMPLETED AND THE ENDOSCOPE WAS REMOVED. THE DISPLAY IN THE PACS VIEWER WAS DOCUMENTED IN A PHOTO. THE PROCESS CAN BE REPRODUCED AT ANY TIME. AN MPPS SERVER HAS NOT YET BEEN USED. NEVERTHELESS, THE POSSIBILITY OF INCORRECT ASSIGNMENT SHOULD BE PREVENTED. WE ARE CURRENTLY STILL WAITING FOR THE CONFORMANCE STATEMENT FROM THE PRACTICE'S DOCUMENTATION SOFTWARE. THIS SHOULD BE DELIVERED LATER. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21015085 ↗MalfunctionDec 16, 2024Poor Quality Image; Overheating of Device; Poor Quality Image; Overheating of Device
B5: THE CONTENT IN THE INITIAL REPORT WAS INSUFFICIENT AND UNCLEAR, SO IT HAS BEEN REVISED AS FOLLOWS. ON 09-DEC-2024 PENTAX MEDICAL BECAME AWARE OF EVENT INVOLVING A MODEL EPK-I8020C, SERIAL NUMBER (B)(6) VIDEO PROCESSOR IN AUSTRALIA WITHIN THE APAC REGION. A USER REPORTED AN ISSUE WHERE ENDOSCOPIC IMAGES TURNED DARK AND RED DURING A PROCEDURE. THE FACILITY USED THE FOLLOWING GASTROSCOPES: - A0038A0455 (EG29-I20C), - Q00Z7AA006 (EG34-I10). BOTH SCOPES EXPERIENCED THE SAME ISSUE, PROMPTING THE USER TO CONTACT A PENTAX MEDICAL REPRESENTATIVE. THEY WERE ADVISED TO USE ANOTHER ENDOSCOPE, BUT THE PROBLEM PERSISTED, REQUIRING A THIRD SCOPE. WHILE THERE WAS NO PHYSICAL HARM TO THE PATIENT, POOR VISIBILITY MADE PROPER OBSERVATION DIFFICULT. THIS RESULTED IN THE NEED FOR MULTIPLE SCOPES, EXTENDING BOTH THE PROCEDURE AND SEDATION TIME BEYOND USUAL. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20936817 ↗MalfunctionNov 21, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20742123 ↗
Other Hoya Corporation products
All Hoya Corporation devices →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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