Single Use Injector NM-401L-0525 (UDI 04953170260094)Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Injector · 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 04953170260094), received between Aug 25, 2022 and Aug 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Flush” (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
- Difficult to Flush1
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 25, 2022Difficult to Flush; Difficult to Flush
THE CUSTOMER (PHYSICIAN) REPORTS DURING AN INJECTION OF STEROID INTO THE VOCAL CORDS PROCEDURE USING A SINGLE USE INJECTOR, TWO INJECTORS WOULD NOT INJECT FLUID (THERE WAS RESISTANCE). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS INJECTOR ONE OF TWO. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS INJECTOR TWO OF TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15294774 ↗
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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