Single Use Injector NM-400U-0425 (UDI 04953170382284)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 04953170382284), received between Jan 12, 2022 and Jan 12, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
- Failure to Deliver2
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.
MalfunctionJan 12, 2022Failure to Deliver; Defective Device; Failure to Deliver; Defective Device
AS REPORTED, CUSTOMER REPORTED AN OUT OF BOX FAILURE (OOB). CUSTOMER REPORTED THAT BOTH NEEDLES WITH MODEL (NM-400U-0425) FAILED TO INJECT DURING A COLONOSCOPY PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13234242 ↗MalfunctionJan 12, 2022Failure to Deliver; Defective Device; Failure to Deliver; Defective Device
AS REPORTED, CUSTOMER REPORTED AN OUT OF BOX FAILURE (OOB). CUSTOMER REPORTED THAT BOTH NEEDLES (NM-400U-0425) FAILED TO INJECT DURING A COLONOSCOPY PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13234215 ↗
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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