BD Luer-Lok 309653Recalls & reported problems
Becton, Dickinson And Company · Syringe 50ml LL Tip · Class 2
Quick summary
This BD Luer-Lok syringe is a piston syringe. The 942 reports mostly describe contamination on the syringe, leaks and splashes, and labels or volume readings that are off, and some note discoloration found when opened. The reports include no deaths and 4 injuries, and 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
- 948
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 948 adverse event reports that list this exact device (DI 00382903096534), received between Jan 19, 2017 and Sep 29, 2026 — classified as 4 injuries, 944 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (298 reports).
10 other recalls cover devices cleared under the same FDA submission (K110771); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material298
- Leak/Splash262
- Contamination89
- Device Markings/Labelling Problem67
- Contamination /Decontamination Problem49
- Volume Accuracy Problem47
- Break44
- Fluid/Blood Leak21
Patient problems
- No Clinical Signs, Symptoms or Conditions482
- No Known Impact Or Consequence To Patient317
- No Patient Involvement62
- No Consequences Or Impact To Patient61
- Insufficient Information18
- No Information4
- Emotional Changes2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 948 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934066 ↗MalfunctionSep 28, 2026Contamination
It was reported, Syringe 50 ML LL, contamination.The following was provided by the initial reporter: I have been notified of 2 more of the 50ml BD syringes that are contaminated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915174 ↗MalfunctionSep 22, 2026Contamination
It was reported, Syringe 50 ML LL, brown spots on tip of syringe. Occurrence 8.The following was provided by the initial reporter: We have had various 50 ml Luer-Lock syringes that have had brown spots on them. The brown spots are on the tip and inside of the plunger.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854708 ↗MalfunctionSep 22, 2026Difficult to Flush; Leak/Splash
Syringe 50 ml LL, The customer reports that the syringe plunger is difficult to move and that the seal allows the medication inside the device to leak out.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853259 ↗MalfunctionSep 22, 2026Difficult to Flush; Leak/Splash
Syringe 50 ml LL, The customer reports that the syringe plunger is difficult to move and that the seal allows the medication inside the device to leak out.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853249 ↗MalfunctionSep 21, 2026Difficult to Flush; Leak/Splash
Syringe 50 ml LL, The customer reports that the syringe plunger is difficult to move and that the seal allows the medication inside the device to leak out.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839593 ↗MalfunctionSep 17, 2026Contamination
It was reported by customer that the syringes have contaminants in them.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808571 ↗MalfunctionSep 15, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779010 ↗MalfunctionSep 13, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747859 ↗MalfunctionSep 13, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747822 ↗MalfunctionSep 8, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676787 ↗MalfunctionSep 7, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658097 ↗MalfunctionSep 7, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652635 ↗MalfunctionSep 7, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652051 ↗MalfunctionSep 7, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652050 ↗MalfunctionSep 2, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567749 ↗MalfunctionAug 28, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499290 ↗MalfunctionAug 26, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456163 ↗MalfunctionAug 24, 2026Unsealed Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421556 ↗MalfunctionAug 24, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419580 ↗MalfunctionAug 24, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419579 ↗MalfunctionAug 24, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419574 ↗InjuryAug 4, 2026Fluid/Blood Leak; Separation Problem
It was reported, Syringe 50ml LL Tip 1ml, The plunger became detached during the preparation of a hazardous medication, causing leak and staff exposure.The following was provided by the initial reporter: This letter serves to formally report a complaint regarding the BD Luer Lok 50 mL syringe, lot numbers 6134989 and 6099628 (lots in circulation at the time of the incident). The plunger became detached during the preparation of a hazardous medication.The preparation is performed in a closed system, and the medication is drawn from a 2 mL vial. This is the first time such an incident has occurred. While pulling back on the plunger to withdraw BCG, the plunger came completely out of the syringe barrel. The plunger's removal caused a spill of hazardous medication, exposing personnel to significant risks. Fortunately, the preparer was wearing appropriate protective equipment, and the spill was quickly contained.For this preparation, the 60 mL syringe used (graduated up to 50 mL) is prefilled with 50 mL of saline. The closed system transfer device is then attached to the syringe tip and to the BCG vial. Next, 2 mL of saline is injected into the vial to dilute the powdered medication. Th
Patient problems: Emotional Changes
MAUDE report 50132945 ↗InjuryAug 4, 2026Fluid/Blood Leak; Separation Problem
It was reported, Syringe 50ml LL Tip 1ml, The plunger became detached during the preparation of a hazardous medication, causing leak and staff exposure.The following was provided by the initial reporter: This letter serves to formally report a complaint regarding the BD Luer Lok 50 mL syringe, lot numbers 6134989 and 6099628 (lots in circulation at the time of the incident). The plunger became detached during the preparation of a hazardous medication.The preparation is performed in a closed system, and the medication is drawn from a 2 mL vial. This is the first time such an incident has occurred. While pulling back on the plunger to withdraw BCG, the plunger came completely out of the syringe barrel. The plunger's removal caused a spill of hazardous medication, exposing personnel to significant risks. Fortunately, the preparer was wearing appropriate protective equipment, and the spill was quickly contained.For this preparation, the 60 mL syringe used (graduated up to 50 mL) is prefilled with 50 mL of saline. The closed system transfer device is then attached to the syringe tip and to the BCG vial. Next, 2 mL of saline is injected into the vial to dilute the powdered medication. Th
Patient problems: Emotional Changes
MAUDE report 50132918 ↗MalfunctionAug 4, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129493 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.
- Z-2614-2026 · Apr 28, 2026 · Open, ClassifiedSYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
- Z-2752-2017 · Sep 16, 2016 · TerminatedBD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
- Z-2753-2017 · Sep 16, 2016 · TerminatedBD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
- Z-2747-2017 · Sep 16, 2016 · TerminatedBD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
- Z-2750-2017 · Sep 16, 2016 · TerminatedBD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
- Z-2749-2017 · Sep 16, 2016 · TerminatedBD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
- Z-2751-2017 · Sep 16, 2016 · TerminatedBD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
- Z-1936-2016 · Mar 25, 2016 · TerminatedHenry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
- Z-1937-2016 · Mar 25, 2016 · TerminatedHenry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
- Z-1055-2015 · Dec 19, 2014 · TerminatedBD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 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
- BD Ultra-Fine 328438Becton, Dickinson and Company Inc · Syringe, piston316 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.