EpiRite Syringes, Non-Toxic, 1mL, Luer Slip, Sterile 6985Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00616784698526), received between Jun 28, 2019 and Dec 5, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2019Device Markings/Labelling Problem

  REFERENCE REPORT NUMBER MW5087168 FOR INCOMPLETE SYRINGE GRADUATIONS. NOTE: AN ADVERSE EVENT DID NOT OCCUR. A PHYSICIAN WAS REPORTING THE ISSUE OF INCOMPLETE GRADUATION MARKINGS ON THE SYRINGE FOR YOUNG CHILDREN. DYNAREX PROVIDES A SYRINGE THAT IS A COMPONENT IN A KIT, AND MAKES NO REFERENCE OR RECOMMENDATIONS REGARDING DOSAGE. IT IS THE RESPONSIBILITY OF THE KIT MANUFACTURER TO DETERMINE SYRINGE SUITABILITY AND APPROPRIATENESS FOR USE AS PART OF THE FINISHED COMBINATION KIT. DYNAREX DID NOT INITIATE THE IFU FOR THE DRUG IN THE PACKAGE INSERT AND CANNOT ACCEPT RESPONSIBILITY FOR PRODUCT INCOMPATIBILITY OR SYRINGE GRADUATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9418977 ↗
• MalfunctionJun 28, 2019Device Markings/Labelling Problem

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745254 ↗