Single Use Injector NM-401L-0523 (UDI 04953170260032)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 04953170260032), received between May 6, 2020 and Jul 6, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Failure to Infuse1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2020Break; Break
WE RECEIVED THE FOLLOWING REPORT. THE TEST WITH THE NEEDLE PRIOR TO USE WAS FLAWLESS. THEN AFTER THE NEEDLE WAS EXTENDED, IT WAS NOT POSSIBLE TO INJECT. THERE WAS NO PATIENT INJURY REPORTED. TWO DEVICES WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON JULY 3, 2020, OMSC FOUND THAT THE SECOND DEVICE WAS NOT POSSIBLE TO INJECT UNDER SOME CONDITION. THIS IS THE REPORT REGARDING THE FAILURE OF THE INJECTION. THIS IS THE SECOND ONE OF TWO REPORTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10237676 ↗MalfunctionMay 6, 2020Failure to Infuse; Failure to Infuse
WE RECEIVED THE FOLLOWING REPORT. THE TEST WITH THE NEEDLE PRIOR TO USE WAS FLAWLESS. THEN AFTER THE NEEDLE WAS EXTENDED, IT WAS NOT POSSIBLE TO INJECT. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FAILURE OF THE INJECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10031242 ↗
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- 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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