InstaClearRecalls & reported problems across all models
Gyrus ACMI, LLC · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one InstaClear model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 19 models of InstaClear by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2020 and Feb 23, 2026 — classified as 2 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
InstaClear 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.
- Apr 3, 2024Open, Classified
Potential for distal end of the sheath to break off during a procedure.
Z-1888-2024 · Root cause: Under Investigation by firm · names 14 of these models · Recall details · FDA record ↗
Most reported InstaClear problems
Device problems
- Detachment of Device or Device Component6
- Break4
- Contamination3
- Defective Device2
- Sharp Edges2
- Deformation Due to Compressive Stress1
- Delivered as Unsterile Product1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Patient Involvement2
- No Consequences Or Impact To Patient1
InstaClear models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InstaClear LCS1500UNOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall2 reports
- InstaClear LCS1800UNSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall1 report
- InstaClear LCS1870BTSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall1 report
- InstaClear LCS1830TPSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1830BTSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1845TPSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1845BTSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1870TPSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1530TPOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1530BTOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1545TPOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1545BTOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1570TPOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1570BTOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS4K30BTOLNasopharyngoscope (Flexible Or Rigid)8 reports
- InstaClear LCTS100SNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 reports
- InstaClear LCS4K45BTOLNasopharyngoscope (Flexible Or Rigid)2 reports
- InstaClear LCS4K00UNOLNasopharyngoscope (Flexible Or Rigid)1 report
- InstaClear LCS4K30TPOLNasopharyngoscope (Flexible Or Rigid)1 report
Recent InstaClear adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT INSTACLEAR SHEATH HAD A PROTRUDING PART IS BENT TOWARD THE TIP. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423818 ↗InjuryJan 13, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ENDOSCOPIC SINUS SURGERY (ESS) PROCEDURE, THE STOPPER AT THE TIP OF THE INSTACLEAR SHEATH BROKE AND FELL INTO THE PATIENT'S NASAL CAVITY. THE BROKEN FRAGMENT WAS RETRIEVED USING FORCEPS. AFTER THE RETRIEVAL, A VISUAL CHECK CONFIRMED NO RESIDUAL FRAGMENTS REMAINED. THE PROCEDURE WAS THEN COMPLETED USING A REPLACEMENT OF THE SAME DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053917 ↗MalfunctionJan 8, 2026Material Deformation; Sharp Edges
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INSTACLEAR SHEATH HAD A POST AT THE DISTAL END THAT WAS BENT UPWARD, RESULTING IN A SHARP EDGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24013876 ↗MalfunctionFeb 12, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21367620 ↗MalfunctionFeb 5, 2025Sharp Edges; Sharp Edges
IT WAS REPORTED THAT WHEN INSTALLING THE DISPOSABLE SHEATH, THE SHEATH WAS OBSERVED TO HAVE JAGGED EDGES AND WAS NOT ABLE TO BE USED. THE CUSTOMER REPORTED THAT THE ISSUE WAS NOTICED OUT-OF-BOX. THERE WAS NO PATIENT OR USER HARM REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315265 ↗MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE INSTACLEAR SHEATH METAL TUBE/PIN HAS DETACHED FROM THE SHEATH (SLEEVE). IT WAS COMPLETE AT THE BEGINNING OF THE PROCEDURE, BUT WAS MISSING/DETACHED AT THE END OF THE PROCEDURE. THE ISSUE OCCURRED DURING A THERAPEUTIC FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369068 ↗MalfunctionAug 8, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE INSTACLEAR SHEATH TIP OF THE SAMPLE SHEATH WAS FUZZY. THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937515 ↗MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTACLEAR SHEATH TIP CAME OFF OUTSIDE OF THE PATIENT¿S BODY. THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937509 ↗MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LENS CLEANING SHEATH WAS DEFECTIVE. THE ISSUE WAS FOUND AT THE START OF A THERAPEUTIC FUNCTIONAL ENDOSCOPIC SINUS SURGERY, WHICH WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19934386 ↗MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LENS CLEANING SHEATH TIP WAS ABOUT TO COME OFF THE SHEATH. THE ISSUE WAS FOUND DURING A PROCEDURE, WHICH WAS COMPLETED WITH A REPLACEMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19934211 ↗MalfunctionJul 11, 2023Contamination; Contamination
IT WAS REPORTED TWO BLACK STAINS OF ABOUT 0.5 MM WERE FOUND ON THE INNER PAPER. THE ISSUE WAS FOUND BEFORE OPENING THE STERILIZED PACK. THE DEVICE WAS REPLACED AND THE PROCEDURE (AN UNSPECIFIED PROCEDURE) WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17296072 ↗InjuryJul 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE INSTACLEAR SYSTEM (INSTACLEAR SHEATH, OLYMPUS 0 DEGREE SCOPE, UNIV POSITION) DURING A THERAPEUTIC ENDOSCOPIC NASAL SURGERY, THE PROTUBERANCE AT THE TIP OF THE LENS CLEANING SHEATH BROKE OFF. IT FELL INTO THE PATIENT¿S NOSE, BUT IT WAS REMOVED AFTER BEING CONFIRMED ON ENDOSCOPIC IMAGE. THE USER NOTED THEY DO NOT KNOW HOW TO PUSH THE RIGID ENDOSCOPE. THERE WERE NO ALLEGATIONS OF PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17294945 ↗MalfunctionNov 17, 2022Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED WHEN THE STERILIZATION PACK WAS LIFTED , THE CONTENTS SUDDENLY FELL OUT AND FOUND THE STERILE PACK WAS NOT SEALED ON THE SIDE OPPOSITE OF THE OPENING. THE ISSUE OCCURRED AT PREPARATION FOR USE FOR A THERAPEUTIC NASAL ENDOSCOPIC SURGERY. THE DEVICE WAS REPLACED. INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15812517 ↗MalfunctionAug 1, 2022Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT WHEN CUSTOMER TOOK OUT THE PRODUCT, " BLACK THINGS" DESCRIBED AS "LIKE A LUMP OF POWDER FOUND " IN THE STERILITY PACK. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE. THE ISSUE FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC OTORHINOLARYNGOLOGY SURGERY. THE INTENDED PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15142045 ↗MalfunctionJan 13, 2022Contamination; Contamination
AS REPORTED, FOREIGN MATTER (LIKE A WOOD CHIPS) FOUND INSIDE THE STERILITY PACK . THE DEVICE WAS REPLACED USING THE SAME TYPE OF DEVICE. THE ISSUE WAS FOUND AT PREPARATION FOR USE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13246908 ↗
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
- M3 Gold5 models · 30 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.
How reports and recalls are matched · Editorial policy · Report an error on this page