Single Use Injector NM-401L-0625 (UDI 04953170382383)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of Single Use Injector (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170382383), received between Apr 20, 2021 and Apr 20, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (2 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, 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 18, 2026.
Most reported problems
Device problems
- Failure to Infuse2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2021Failure to Infuse; Failure to Infuse
THE DOCTOR AT THE USER FACILITY REPORTED THE EVENT OCCURRED DURING A STEROID INJECTION PROCEDURE FOR PATIENT WITH SUBGLOTTIC STENOSIS. THE DEVICE FAILED WHEN THEY TRIED TO INJECT INTRALESIONALLY. NO OTHER DEVICES WERE REPLACED DURING THE PROCEDURE. THERE WERE NO PATIENT INJURIES, BUT A PROLONGED PROCEDURE AND A REPEAT PROCEDURE WAS REQUIRED. THE INSTRUMENT WAS INSPECTED BEFORE USE FOR DAMAGE, ABNORMALITIES, AND IRREGULARITIES. THE INSTRUMENT WAS ALSO TESTED, AND IT WORKED PRIOR TO INJECTION. NO DEVICE WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11694278 ↗MalfunctionApr 20, 2021Failure to Infuse; Failure to Infuse
THE DOCTOR AT THE USER FACILITY REPORTED THE EVENT OCCURRED DURING A STEROID INJECTION PROCEDURE FOR PATIENT WITH SUBGLOTTIC STENOSIS. THE DEVICE FAILED WHEN THEY TRIED TO INJECT INTRALESIONALLY. NO OTHER DEVICES WERE REPLACED DURING THE PROCEDURE. THERE WERE NO PATIENT INJURIES, BUT A PROLONGED PROCEDURE AND A REPEAT PROCEDURE WAS REQUIRED. THE INSTRUMENT WAS INSPECTED BEFORE USE FOR DAMAGE, ABNORMALITIES, AND IRREGULARITIES. THE INSTRUMENT WAS ALSO TESTED, AND IT WORKED PRIOR TO INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11694267 ↗
Other endoscopic injection needle, gastroenterology-urology devices
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- n.a. 27182AKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- n.a. 27030NKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 70cm DIS201Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 35cm DIS199Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology28 reports
- Single Use Injector NM-401L-0423Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology27 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology26 reports
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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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