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Single Use Injector NM-401L-0625 (UDI 04953170260117)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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170260117), received between May 26, 2023 and May 26, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (3 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

  • Failure to Deliver3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 26, 2023Failure to Deliver; Failure to Deliver

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A SINGLE USE INJECTOR, TWO NEEDLES WERE UNABLE TO PUSH MEDICATION AND ANOTHER NEEDLE WOULD NOT RETRACT OUT OF A BOX OF FIVE. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE (BRONCHOSCOPY WITH SUBGLOTTIC KENALOG INJECTION) AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT UNDER ANESTHESIA AT THE TIME. THERE WAS A PROCEDURAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF UNABLE TO PUSH MEDICATION. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17010700 ↗
  • MalfunctionMay 26, 2023Failure to Deliver; Failure to Deliver

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A SINGLE USE INJECTOR, TWO NEEDLES WERE UNABLE TO PUSH MEDICATION AND ANOTHER NEEDLE WOULD NOT RETRACT OUT OF A BOX OF FIVE. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE (VOCAL CORD INJECTION). THERE WAS NO PATIENT UNDER ANESTHESIA AT THE TIME. THE PROCEDURE WAS COMPLETED AFTER MULTIPLE ATTEMPTS. THERE WAS A PROCEDURAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF UNABLE TO PUSH MEDICATION. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17010572 ↗
  • MalfunctionMay 26, 2023Failure to Deliver; Failure to Deliver

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A SINGLE USE INJECTOR, TWO NEEDLES WERE UNABLE TO PUSH MEDICATION AND ANOTHER NEEDLE WOULD NOT RETRACT OUT OF A BOX OF FIVE. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE (VOCAL CORD INJECTION). THERE WAS NO PATIENT UNDER ANESTHESIA AT THE TIME. THE PROCEDURE WAS COMPLETED AFTER MULTIPLE ATTEMPTS. THERE WAS A PROCEDURAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF UNABLE TO PUSH MEDICATION. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17010530 ↗

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Sources and updates

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