McKesson 16-305180Recalls & reported problems
Mckesson Medical-Surgical Inc. · Blunt Fill Needle · Class 1
Data updated Oct 16, 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 00612479230859), received between May 16, 2025 and Jul 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THE BLUNT FILL NEEDLES HAVE BEEN CORING THE RUBBER STOPPERS ON VIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585509 ↗MalfunctionMay 16, 2025Break; Break
THE CUSTOMER REPORTED THAT THE NEEDLE IS BREAKING OFF IN HIGH-VALUE PRESCRIPTION PRODUCTS, CAUSING THEM UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035725 ↗
Other Needle, Aspiration And Injection, Disposable devices
- N/A 305211Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE425 reports
- N/A 305180Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE300 reports
- N/A 305200Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE99 reports
- PneumoDart TM-317TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall1 report
- TPAK TM-303TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall0 reports
- N/A 305181Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE32 reports
- SOL-M™ Blunt Fill Needle with 5 Micron Filter 110022Sol-Millennium Medical, Inc. · Needle, Aspiration And Injection, Disposable17 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283903611Medos International Sàrl · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE17 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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