BD Eclipse Needle 303304Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903033041), received between Nov 19, 2024 and Sep 9, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K161170); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695163 ↗
• MalfunctionAug 21, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374245 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT THEY GO TO ENGAGE THE PROTECTIVE GUARD, THE GUARD IT IS POPPING OFF OR THE NEEDLE IS COMING OFF THE SYRINGE. THE NURSING TEAM HAS REPORTED TO ME RECENT ISSUES WITH THE 23 G BD ECLIPSE NEEDLE. THEY ARE STATING WHEN THEY GO TO ENGAGE THE PROTECTIVE GUARD, THE GUARD IT IS POPPING OFF OR THE NEEDLE IS COMING OFF THE SYRINGE. CAN WE TAKE A LOOK AT THIS? PLEASE SEE THE LOT AND PRODUCT INFORMATION BELOW: BD ECLIPSE NEEDLE 23G 11/2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378832 ↗
• MalfunctionFeb 18, 2026Break; Material Separation

  IT WAS REPORTED BY CUSTOMER THAT THEY GO TO ENGAGE THE PROTECTIVE GUARD, THE GUARD IT IS POPPING OFF OR THE NEEDLE IS COMING OFF THE SYRINGE. THE NURSING TEAM HAS REPORTED TO ME RECENT ISSUES WITH THE 23 G BD ECLIPSE NEEDLE. THEY ARE STATING WHEN THEY GO TO ENGAGE THE PROTECTIVE GUARD, THE GUARD IT IS POPPING OFF OR THE NEEDLE IS COMING OFF THE SYRINGE. CAN WE TAKE A LOOK AT THIS? PLEASE SEE THE LOT AND PRODUCT INFORMATION BELOW: BD ECLIPSE NEEDLE 23G 11/2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378831 ↗
• MalfunctionNov 21, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL # 303304, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY GIVE THE INJECTION, THE SYRINGE IS NOT FULLING EMPTYING. VERBATIM: I HAD ONE OF OUR PHYSICIAN OFFICES REACH OUT THIS PAST WEEK ABOUT SOME ISSUES WHEN GIVING CORTISONE SHOTS. THEY ARE REPORTING THAT WHEN THEY GIVE THE INJECTION, THE SYRINGE IS NOT FULLING EMPTYING. THE NEEDLE USED IS 23GX1.5¿ ECLIPSE SKU# 303304 WITH A 10ML LL SYRINGE SKU# 302995. ORIGINALLY WE THOUGHT THERE MAY HAVE BEEN AN ISSUE WITH THE NEEDLE-SO THEY NOTED THE LOT AND REMOVED THAT LOT FROM USE. WHEN ANOTHER NEEDLE WAS USED, THERE WERE STILL ISSUES. THEY ARE IN THE PROCESS OF REMOVING THE LOT OF SYRINGE AND WE WILL BE SENDING NEW PRODUCT TO THEM. I¿LL ALSO BE WORKING INTERNALLY WITH THE PHARMACY TO SEE IF THERE COULD HAVE BEEN A CHANGE IN THE MEDICATION VISCOSITY. THIS IS A BONE & JOINT PRACTICE SO THIS IS A FREQUENT PROCEDURE, AND THEY ARE JUST NOW HAVING PROBLEMS SO IT SEEMS SOMETHING HAS CHANGED. HAVE YOU HEARD OF ANY ISSUES WITH THESE NEEDLES OR SYRINGES? I BELIEVE OUR CURRENT NEEDLE IS LISTED AS ¿THIN WALLED¿, IS THERE AN ALTERNATIVE NEEDLE? I HAVE THE LOT OF NEEDLES AND WILL REQUEST THE SYRINGES SHOULD A PRODUCT COMPLAINT NEED TO BE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746219 ↗
• MalfunctionNov 19, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 303304, BATCH#: UNKNOWN. IT WAS REPORTED, BY THE CUSTOMER. THAT THE NEEDLE WAS USED FOR IM INJECTION, FOR THE VENTROGLUTEAL SITE OF THE PATIENT RECEIVING WHINRO MEDICATION. A LEAK WAS NOTED, ON THE CONNECTING PORT. THE NEEDLE WAS SCREWED TIGHT, PRIOR TO ADMINISTRATION. AFTER THE LEAK, THE NEEDLE WAS CHANGED. AND NO LEAK WAS NOTED, ON THE NEW NEEDLE LEVEL OF HARM: NO APPARENT HARM REACHED PATIENT/PERSON, INCONVENIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727195 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161170. One submission often covers many models, so check the product and lot details in each record.

• Z-1440-2017 · Dec 20, 2016 · Terminated
  Eclipse Hypodermic Needle