Single Use Injector NM-400L-0423 (UDI 04953170382192)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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170382192), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Restricted Flow rate” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Restricted Flow rate; Restricted Flow rate
THE CUSTOMER REPORTED THAT AN OLYMPUS SINGLE-USE INJECTION NEEDLE MALFUNCTIONED DURING A THERAPEUTIC PROCEDURE. ACCORDING TO THE INITIAL REPORTER, AFTER REMOVING THE SUBJECT DEVICE FROM THE PACKAGE, AN ATTEMPT WAS MADE TO IRRIGATE THE SYRINGE, BUT IT FAILED DUE TO THE NEEDLE HAVING AN OBSTRUCTION PRESENT. REPORTEDLY, SEVERAL MORE ATTEMPTS WERE MADE, BUT THE USER ULTIMATELY HAD TO SWITCH TO ANOTHER INJECTOR TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853651 ↗
Other endoscopic injection needle, gastroenterology-urology devices
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- 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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