Single Use Injector NM600/610 NM-610U-0426Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Injector NM600/610 · Class 2
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 04953170422874), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
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 30, 2022Contamination; Contamination
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN PROCEDURE THE CUSTOMER HAD DIFFICULTY IN OPENING THE SEALED PACKAGE OF THE DEVICE. THIS DEVICE IS SEALED WITH AN ADDITIONAL SEAL PACKAGE. SINCE THE CUSTOMER HAD TO FORCIBLY OPEN THE PACKAGE, THERE IS A CHANCE OF CONTAMINATION BY CONTACT WITH AN UNCLEAN AREA. CUSTOMER IS RECOMMENDING THAT THE PACKAGE SEAL BE IMPROVED FOR EASE OF OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322163 ↗
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- 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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