MEDLINE SSN100253Recalls & reported problems
Medline Industries, Inc. · NEEDLE,HYPODERM,SAFETY, 25GX5/8 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10193489031973), received between Mar 7, 2023 and Sep 24, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Disconnection5
- Break2
- Insufficient Device Problem Information2
- Loose or Intermittent Connection2
- Connection Problem1
- Device Slipped1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Needle Stick/Puncture3
- Insufficient Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884396 ↗MalfunctionSep 21, 2026Break
Patient problems: Needle Stick/Puncture
MAUDE report 50848799 ↗MalfunctionSep 17, 2026Disconnection
It was reported that this needle is not securing onto the syringes and falling off before and after administration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802185 ↗MalfunctionSep 16, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789432 ↗MalfunctionSep 16, 2026Disconnection; Detachment of Device or Device Component; Positioning Problem
It was reported that needle cap falls off when removing from packaging, the safety device will not stay in an open position. The needles are twisting itself off the syringe which has happen with both plastic and glass syringes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785955 ↗MalfunctionSep 14, 2026Break; Detachment of Device or Device Component
Patient problems: Needle Stick/Puncture
MAUDE report 50763114 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755901 ↗MalfunctionSep 14, 2026Connection Problem
It was reported that "needles are popping off and not locking on" and "the needles were not locking on when they went to attached with prefilled syringe."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754516 ↗MalfunctionSep 13, 2026Disconnection; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747953 ↗MalfunctionSep 13, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747794 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741222 ↗MalfunctionSep 11, 2026Device Slipped; Detachment of Device or Device Component
Patient problems: Needle Stick/Puncture
MAUDE report 50740863 ↗MalfunctionSep 10, 2026Loose or Intermittent Connection
The report states, "Drawing up a varicella vaccine and when I inserted the needle into the rubber hub the needle (metal piece only) snapped off and dropped onto the counter. No harm was done at the time, but if this needle had been inserted into a patient it would have snapped off and been in the patients leg or arm."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713414 ↗MalfunctionFeb 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
UNABLE TO PUSH VACCINE OUT WHEN NEEDLE ATTACHED TO SYRINGE.
Patient problems: Insufficient Information
MAUDE report 21375376 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER DOUBT THE VOLUMN IS UNCORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102934 ↗MalfunctionMar 7, 2023Material Integrity Problem; Material Integrity Problem
MEDICATION LEAKED REQUIRING SECOND ADMINISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16498816 ↗
Other Syringe, piston devices
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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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