Medline SYR160010Recalls & reported problems
Medline Industries, Inc. · SYRINGE, LUER LOCK, 60ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medline luer-lock syringe is a large-capacity syringe with a plastic plunger handle. The 34 reports filed between February 2024 and August 2024 mostly describe contamination — specks of material, hair or other particles found inside the barrel — along with plastic handles cracking when pushed, fluid leaking from the plunger, and syringes that felt loose or hard to operate. All 34 are malfunctions, with no deaths and no injuries reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 30080196310245), received between Feb 22, 2024 and Aug 22, 2024 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Contamination” (17 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination17
- Appropriate Device Problem Term/Code Not Available5
- Material Integrity Problem3
- Fluid/Blood Leak2
- Break1
- Connection Problem1
- Inadequacy of Device Shape and/or Size1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CONTAMINATE IN SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20023778 ↗MalfunctionJun 26, 2024Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY THE PLASTIC HANDLES CRACKED/SNAPPED WHEN PUSHING THE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19615568 ↗MalfunctionApr 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY THERE WAS PARTICULATE INSIDE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080117 ↗MalfunctionApr 9, 2024Incorrect Measurement; Incorrect Measurement
"SYRINGES MIGHT BE SLIGHTLY UNDER".
Patient problems: Insufficient Information
MAUDE report 19075809 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046885 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046691 ↗MalfunctionApr 4, 2024Contamination; Contamination
IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046478 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE SYRINGE WAS "TOO DIFFICULT TO USE" AND THAT LEAKAGE FROM THE PLUNGER WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040698 ↗MalfunctionApr 4, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE LUER LOCK TIP OF THE SYRINGE BROKE OFF WHILE DETACHING IT FROM A SOLUTION BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040697 ↗MalfunctionApr 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SYRINGE WAS "SHORT AND FAT AND IT DOESN'T FIT OUR PUMPS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039018 ↗MalfunctionApr 3, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038470 ↗MalfunctionApr 2, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE SYRINGE DID NOT CONNECT TO ANESTHESIA SYRINGE PUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016923 ↗MalfunctionApr 2, 2024Contamination; Contamination
IT WAS REPORTED THAT FOREIGN PARTICULATE WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016920 ↗MalfunctionApr 2, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS "EXTREMELY DIFFICULT TO ADVANCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016919 ↗MalfunctionApr 1, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR AND AN "OILY SUBSTANCE" WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016887 ↗MalfunctionApr 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE SYRINGE WAS "SHORTER THAN USUAL" AND DID NOT FIT INTO A PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016886 ↗MalfunctionApr 1, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR AND AN "OILY SUBSTANCE" WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016883 ↗MalfunctionApr 1, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT SYRINGES ARE RECEIVED WITH THE PLUNGER "CRACKED/BROKEN OR MISSING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016848 ↗MalfunctionApr 1, 2024Contamination; Contamination
ACCORDING TO THE CUSTOMER ON 2/28/2024, "DURING COMPOUNDING, IT WAS NOTED BY A PHARMACY TECHNICIAN THAT A VISIBLE HAIR WAS PRESENT IN A 60 ML SYRINGE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016389 ↗MalfunctionMar 31, 2024Contamination; Contamination
IT WAS REPORTED THAT A "BLACK, HAIR-LIKE FIBER" WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009242 ↗MalfunctionMar 30, 2024Contamination; Contamination
IT WAS REPORTED THAT A "BLACK FIBER" WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009148 ↗MalfunctionMar 29, 2024Contamination; Contamination
IT WAS REPORTED THAT "DEBRIS" WAS FOUND WHILE USING THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008733 ↗MalfunctionMar 28, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001400 ↗MalfunctionMar 24, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966437 ↗MalfunctionMar 24, 2024Contamination; Contamination
IT WAS REPORTED THAT HAIR WAS NOTED WITHIN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966436 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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