Safety Needle 25G x 1''Recalls & reported problems
Anhui Hongyu Wuzhou Medical Manufacturer CO Ltd · A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06958697602318), received between Nov 23, 2022 and Nov 23, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Protrusion/Extrusion1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
STAFF WERE PLACING THE NEEDLE ON THE SYRINGE TO ADMINISTER THE VACCINE TO THE PATIENT AND THE SAFETY MECHANISM OF THE NEEDLE CAME OFF. NO NEEDLE STICK OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15850418 ↗MalfunctionNov 23, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
NEEDLE WAS STICKING OUT OF SAFETY SHEATH AFTER MECHANISM WAS ENGAGED. THIS CAUSED A STAFF NEEDLE STICK AFTER VACCINE ADMINISTRATION.
Patient problems: Needle Stick/Puncture
MAUDE report 15850413 ↗
Other Needle, Hypodermic, Single Lumen devices
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- 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.
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