Single Use InjectorRecalls & reported problems across all models
Olympus Medical Systems Corp. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 230
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 29 models of Single Use Injector by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 230 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2019 and Sep 15, 2026 — classified as 10 injuries, 220 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (49 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. 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
Most reported Single Use Injector problems
Device problems
- Failure to Deliver49
- No Flow40
- Infusion or Flow Problem26
- Mechanical Problem26
- Failure to Infuse21
- Obstruction of Flow12
- Activation Failure9
- Failure to Discharge8
Patient problems
- No Clinical Signs, Symptoms or Conditions208
- No Consequences Or Impact To Patient11
- Hemorrhage/Blood Loss/Bleeding3
- Cough2
- Foreign Body In Patient2
- Abdominal Pain1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blood Protein Abnormal1
Single Use Injector models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Injector NM-401L-0425endoscopic injection needle, gastroenterology-urology28 reports
- Single Use Injector NM-401L-0423endoscopic injection needle, gastroenterology-urology27 reports
- Single Use Injector NM-401L-0425endoscopic injection needle, gastroenterology-urology26 reports
- Single Use Injector NM-401L-0423endoscopic injection needle, gastroenterology-urology20 reports
- Single Use Injector NM-401L-0623endoscopic injection needle, gastroenterology-urology16 reports
- Single Use Injector NM-400U-0423endoscopic injection needle, gastroenterology-urology13 reports
- Single Use Injector NM-400U-0425endoscopic injection needle, gastroenterology-urology12 reports
- Single Use Injector NM-401L-0425endoscopic injection needle, gastroenterology-urology11 reports
- Single Use Injector NM-401L-0525endoscopic injection needle, gastroenterology-urology11 reports
- Single Use Injector NM-401L-0523endoscopic injection needle, gastroenterology-urology9 reports
- Single Use Injector NM-401L-0423Endoscopic Injection Needle, Gastroenterology-Urology9 reports
- Single Use Injector NM-401L-0423endoscopic injection needle, gastroenterology-urology7 reports
- Single Use Injector NM-400U-0423endoscopic injection needle, gastroenterology-urology7 reports
- Single Use Injector NM-401L-0523endoscopic injection needle, gastroenterology-urology5 reports
- Single Use Injector NM-400U-0425endoscopic injection needle, gastroenterology-urology3 reports
- Single Use Injector NM-401L-0625endoscopic injection needle, gastroenterology-urology3 reports
- Single Use Injector NM-401L-0425Endoscopic Injection Needle, Gastroenterology-Urology3 reports
- Single Use Injector NM-400L-0423Endoscopic Injection Needle, Gastroenterology-Urology3 reports
- Single Use Injector NM-400L-0423endoscopic injection needle, gastroenterology-urology2 reports
- Single Use Injector NM-401L-0523endoscopic injection needle, gastroenterology-urology2 reports
- Single Use Injector NM-400U-0425endoscopic injection needle, gastroenterology-urology2 reports
- Single Use Injector NM-401L-0525endoscopic injection needle, gastroenterology-urology2 reports
- Single Use Injector NM-401L-0625endoscopic injection needle, gastroenterology-urology2 reports
- Single Use Injector NM-400U-0525endoscopic injection needle, gastroenterology-urology2 reports
- Single Use Injector NM-401L-0525endoscopic injection needle, gastroenterology-urology1 report
- Single Use Injector NM-400L-0423endoscopic injection needle, gastroenterology-urology1 report
- Single Use Injector NM-400Y-0423Endoscopic Injection Needle, Gastroenterology-Urology1 report
- Single Use Injector NM-401L-0623Endoscopic Injection Needle, Gastroenterology-Urology1 report
- Single Use Injector NM-401L-0525Endoscopic Injection Needle, Gastroenterology-Urology1 report
Recent Single Use Injector adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Failure to Deliver
It was reported the single use injector's needle wouldn't allow fluid through when in the out position. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778855 ↗MalfunctionSep 8, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673679 ↗MalfunctionAug 6, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150778 ↗MalfunctionAug 4, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129162 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT THE SOLUTION HAD COME OUT OF THE SINGLE USE INJECTOR'S SHEATH AND NOT THE NEEDLE. THE REPORTED ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE, WHICH WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233649 ↗MalfunctionApr 15, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INJECTOR AND SHEATH SET HAD A SEVERE KINK IN THE TUBE SHEATH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887642 ↗MalfunctionApr 9, 2026Activation, Positioning or Separation Problem; No Flow
IT WAS REPORTED THE SINGLE USE INJECTOR WOULD NOT INJECT LIQUID. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837635 ↗MalfunctionApr 6, 2026Failure to Deliver
IT WAS REPORTED THE SINGLE-USE INJECTOR WAS UNABLE TO INJECT BOTOX WHEN THE NEEDLE WAS FULLY EXTENDED. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794074 ↗MalfunctionDec 19, 2025Break; Break
NO NEW ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850283 ↗MalfunctionDec 3, 2025Corroded; Corroded
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705822 ↗MalfunctionDec 3, 2025Corroded; Corroded
IT WAS REPORTED THAT THE SINGLE USE INJECTOR SHOWED SIGNS OF CORROSION NEAR THE NEEDLE TIP. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705790 ↗MalfunctionDec 3, 2025Corroded; Corroded
IT WAS REPORTED THAT THE SINGLE USE INJECTOR HAD A RUSTY NEEDLE. THIS WAS FOUND DURING PREPARATION FOR USE; THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705671 ↗MalfunctionDec 3, 2025Corroded; Corroded
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705533 ↗MalfunctionDec 2, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT THE SINGLE USE INJECTOR MALFUNCTIONED DURING THE INJECTION OF BOTOX INTO THE VOCAL FOLDS. THE SYRINGE PLUNGER WAS REPORTED TO HAVE BEEN FORCED BACK. THE DOCTOR ASKED THE STAFF TO REATTACH THE SYRINGE TO THE INJECTOR TO ATTEMPT THE INJECTION A SECOND TIME. AGAIN, THE SYRINGE WAS FULLY PRESSED, APPEARING TO DELIVER THE MEDICATION, BUT THE SYRINGE PLUNGER BOUNCED BACK WHEN THE USER'S THUMB WAS REMOVED FROM PLUNGER. THERE WERE NO REPORTS PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23698041 ↗MalfunctionOct 31, 2025Activation, Positioning or Separation Problem
OLYMPUS INJECTOR FORCE 25G NEEDLE WOULD NOT DEPLOY OUT OF SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435743 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
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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