BD EclipseTM Needle 25G x 5/8"TW 305829Recalls & reported problems
Becton, Dickinson And Company · BD EclipseTM Needle 25G x 5/8"TW · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903058297), received between Apr 3, 2024 and Feb 21, 2025 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Complete Blockage2
- Defective Component2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Needle Stick/Puncture2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X5/8 NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RESPONSE ON FEB 03, 2025 FOLLOW-UP 2 FOR (B)(4). MY PROVIDER HAS ENCOUNTERED IN THE PAST COUPLE WEEKS (PRIOR TO (B)(6) 2025) THE BD ECLIPSE NEEDLE 305829 UNUSABLE, DUE TO BEING "PLUGGED" CANNOT PUSH MEDICATION. IT DOES NOT HAPPEN WITH EVERY NEEDLE. WE PULLED THE NEEDLES AND SET ASIDE AT THIS TIME. I CHECKED THE WEBSITE AND DID NOT SEE A RECALL. HAVE THERE BEEN ANY ADDITIONAL REPORTS? TWO OCCURRENCES AT THE LOCATION, BUT THE PROVIDER NOTED OCCURRENCES AT OTHER LOCATIONS. I DO NOT HAVE THE INFORMATION REGARDING LOT# ETC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21438622 ↗MalfunctionFeb 4, 2025Complete Blockage; Complete Blockage
MATERIAL # 305829 BATCH # 2271572 IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X5/8 NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿MY PROVIDER HAS ENCOUNTERED IN THE PAST COUPLE WEEKS THE BD ECLIPSE NEEDLE 305829 UNUSABLE, DUE TO BEING "PLUGGED" CANNOT PUSH MEDICATION. IT DOES NOT HAPPEN WITH EVERY NEEDLE. WE PULLED THE NEEDLES AND SET ASIDE AT THIS TIME. LOT# 2271572.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309614 ↗MalfunctionOct 1, 2024Defective Component; Defective Component
IMDRF CODES MUST BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343209 ↗InjuryJun 13, 2024Defective Component; Defective Component
MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
MATERIALS#: 305829. BATCH#: UNKNOWN, 3330684 AND 2271572. IT WAS REPORTED THAT THE BD ECLIPSETM NEEDLE 25G X 5/8"TW SAFETY SHIELD BROKE OFF (ECLIPSE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ECLIPSE NEEDLES SAFETY ACTIVATION IS BREAKING.". VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCTCOMPLAINT-MDS FACILITY: XXXX XXXXX XXXXX XXXXX ADDRESS: XXXXXX XXXX XXXXX XXXX XX XXXX CONTACT: XXXXX XXXX-MANGER DEPT: AMBULATORY PHONE: XXX-XXX-XXXXX CELL EMAIL: [email protected] CONTACT: XXXXXX XXXXX-DIRECTOR OF AMBULATORY QUALITY MANAGMENT PHONE: XXXX-XXXX-XXXXX EMAL: [email protected] ISSUE: ECLIPSE NEEDLES SAFETY ACTIVATION IS BREAKING REF: 305829 LOT: UNKNOWN, 3330684 AND 2271572. DOE: MULTIPLE DOE WILL SEND THEM WHEN THE ACKNOWLEDGEMENT IS SENT OUT PT HARM: NO. ADDITIONAL INFORMATION PROVIDED: DATES OF OCCURRENCES: 04/11/2024, 04/16/2024, 04/18/2024, 05/02/2024 (FOUR DIFFERENT USERS REPORTING THIS ISSUE). I DO NOT HAVE NOTES OF WHAT LOT NUMBERS IMPACTED WHICH DATES. IF WE HAVE ADDITIONAL OCCURRENCES, I WILL MAKE SURE TO HAVE THE STAFF NOTATE THIS. WE HAD SEVERAL OCCURRENCES BEFORE THIS WAS NOTED TO BE A SIGNIFICANT RISK EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19463365 ↗MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
InjuryApr 3, 2024Defective Device; Defective Device
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 · TerminatedEclipse Hypodermic Needle
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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.
How reports and recalls are matched · Editorial policy · Report an error on this page