Single Use Injector NM600/610 NM-610U-0425Recalls & reported problems
Olympus Medical Systems Corp. · 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 04953170378058), received between Jun 26, 2020 and Jun 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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
- Device Damaged Prior to Receipt by User1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2020Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem; Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem
AS REPORTED FOR THIS EVENT, UPON DELIVERY RECEIPT INSPECTION, IT WAS OBSERVED THAT THE OUTER PACKAGING BOX IN WHICH WERE PACKED FIVE BOXES OF THE DEVICE WAS DAMAGED. THIS IN TURN DAMAGED THE FOUR OUT OF THE FIVE BOXES WITH THE POTENTIAL OF COMPROMISING THE STERILITY OF THE TWENTY DEVICES WITHIN. WHEN DURING SHIPMENT THE DAMAGE WAS CAUSED IS NOT KNOWN.
Patient problems: No Patient Involvement
MAUDE report 10201626 ↗
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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