BD Luer-LokRecalls & reported problems across all models
Becton, Dickinson And Company · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5,117
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 48 models of BD Luer-Lok by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 5,117 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2016 and Sep 30, 2026 — classified as 39 injuries, 5,078 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (1,460 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Luer-Lok problems
Device problems
- Leak/Splash1,460
- Device Contamination with Chemical or Other Material1,160
- Volume Accuracy Problem380
- Contamination /Decontamination Problem315
- Break301
- Device Markings/Labelling Problem293
- Contamination238
- Defective Component188
Patient problems
- No Clinical Signs, Symptoms or Conditions2,664
- No Known Impact Or Consequence To Patient1,623
- No Consequences Or Impact To Patient399
- No Patient Involvement251
- Insufficient Information68
- No Information49
- Needle Stick/Puncture20
- Chemical Exposure8
BD Luer-Lok models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Luer-Lok 309657Syringe, piston1,266 reports
- BD Luer-Lok 309653Syringe, piston948 reports
- BD Luer-Lok 309628Syringe, piston862 reports
- BD Luer-Lok 309646Syringe, piston311 reports
- BD Luer-Lok 309605Syringe, piston228 reports
- BD Luer-Lok 309703Syringe, piston165 reports
- BD Luer-Lok 309702Syringe, piston148 reports
- BD Luer-Lok 309680Syringe, piston146 reports
- BD Luer-Lok 309604Syringe, piston103 reports
- BD Luer-Lok 305617Syringe, piston90 reports
- BD Luer-Lok 305060Syringe, piston84 reports
- BD Luer-Lok 303310Syringe, piston82 reports
- BD Luer-Lok 309695Syringe, piston78 reports
- BD Luer-Lok 309581Syringe, piston74 reports
- BD Luer-Lok 305618Syringe, piston60 reports
- BD Luer-Lok 309570Syringe, piston56 reports
- BD Luer-Lok 309642Syringe, piston56 reports
- BD Luer-Lok 309575Syringe, piston54 reports
- BD Luer-Lok 309571Syringe, piston31 reports
- BD Luer-Lok 309572Syringe, piston29 reports
- BD Luer-Lok 309632Syringe, piston26 reports
- BD Luer-Lok 309644Syringe, piston24 reports
- BD Luer-Lok 309580Syringe, piston23 reports
- BD Luer-Lok 305064Syringe, piston20 reports
- BD Luer-Lok 309574Syringe, piston17 reports
- BD Luer-Lok 309578Syringe, piston17 reports
- BD Luer-Lok 309579Syringe, piston16 reports
- BD Luer-Lok 305062Syringe, piston14 reports
- BD Luer-Lok 309582Syringe, piston11 reports
- BD Luer-Lok 309589Syringe, piston10 reports
- BD Luer-Lok 309569Syringe, piston9 reports
- BD Luer-Lok 309643Syringe, piston9 reports
- BD Luer-Lok 309577Syringe, piston9 reports
- BD Luer-Lok 309645Syringe, piston7 reports
- BD Luer-Lok 309634Syringe, piston5 reports
- BD Luer-Lok 309631Syringe, piston4 reports
- BD Luer-Lok 309633Syringe, piston4 reports
- BD Luer-Lok 405727Anesthesia conduction kit4 reports
- BD Luer-Lok 309588Syringe, piston3 reports
- BD Luer-Lok 309635Syringe, piston3 reports
- BD Luer-Lok 309629Syringe, piston3 reports
- BD Luer-Lok 309585Syringe, piston2 reports
- BD Luer-Lok 301604Syringe, piston1 report
- BD Luer-Lok 309598Syringe, piston1 report
- BD Luer-Lok 309637Syringe, piston1 report
- BD Luer-Lok 309640Syringe, piston1 report
- BD Luer-Lok 309650Syringe, piston1 report
- BD Luer-Lok 309661Syringe, piston1 report
Recent BD Luer-Lok adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954907 ↗MalfunctionSep 30, 2026Leak/Splash
It was reported by the customer that seventy syringes were found to be leaking. Verbatim: Complaint via Email. Email attached. On (b)(6)2026, During post production visual inspection of lot #20260825-383BBA Succinylcholine chloride 100mg/5mL (20mg/1mL), seventy syringes were found to be leaking. These units are not available for return. ¿ Product: Sterile Syringe Tray 5mL (70 Syringes).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949384 ↗MalfunctionSep 29, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934066 ↗MalfunctionSep 28, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923618 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918133 ↗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 25, 2026Leak/Splash
It was reported that BD SYRINGE 3ML LL 200 S/C had leakage.Verbatim: Complaint via Email. Email attachedReference Number (ID): 22907Date of Incident (yyyy-mm-dd): 2026-09-08Type of incident/problem: A1. Defect (observed prior to use)Level of harm: No effect - did not reach patient/person -- detected before use or does not touch patient before useIncident Details: I was dividing an Ultrasound enhancing agent (Definity) into three 3ml syringes when I pulled the definity back into the syringe, the definity leaked back through the plunger.Frequency of problem: First timeInvasive procedure? NoDevice InformationDevice Name/Description: SYRINGE LUER LOCK TIP 3MLManufacturer: Manufacturer code/model: 309657Serial or Lot number: (b)(6)Expiry date: 2030-12-31Supplier: Supplier/Catalogue number: 308-309657Is the device retained? YesInvestigation RequestExpected type of investigation: Actual Device Tested; Lot Review;E-mail Address for Person holding device:Site shipping address: Clinical Contact Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900125 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
It was reported by customer that multiple product quality concerns that have been identified with BD sterile syringes from several lots. Verbatim: Complaint via Email. Email attached. I am writing to report multiple product quality concerns that have been identified with BD sterile syringes from several lots currently in our inventory. These issues have been observed across multiple syringes and lot numbers, raising concerns regarding product quality and manufacturing consistency. The defects identified include: Extra measurement markings printed on syringe barrels Black specks present on syringe barrels Unidentifiable debris observed within syringe barrels Missing graduation markings on the barrel The affected products and lot numbers are as follows: 50 mL Sterile Syringes Lot 6138808: Two syringes identified with defects Lot 6098162: Two syringes identified with defects Lot 6098177: Two syringes identified with defects Lot 6131767: 26 Defective syringes identified 5 mL Sterile Syringe Lot 6114407: One syringe identified with missing graduation markings on the side of the barrel These defects were identified during routine inspection. Due to concerns regarding product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899381 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
It was reported by customer that multiple product quality concerns that have been identified with BD sterile syringes from several lots. Verbatim: Complaint via Email. Email attached. I am writing to report multiple product quality concerns that have been identified with BD sterile syringes from several lots currently in our inventory. These issues have been observed across multiple syringes and lot numbers, raising concerns regarding product quality and manufacturing consistency. The defects identified include: Extra measurement markings printed on syringe barrels Black specks present on syringe barrels Unidentifiable debris observed within syringe barrels Missing graduation markings on the barrel The affected products and lot numbers are as follows: 50 mL Sterile Syringes Lot 6138808: Two syringes identified with defects Lot 6098162: Two syringes identified with defects Lot 6098177: Two syringes identified with defects Lot 6131767: 26 Defective syringes identified 5 mL Sterile Syringe Lot 6114407: One syringe identified with missing graduation markings on the side of the barrel These defects were identified during routine inspection. Due to concerns regarding product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899380 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899355 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
It was reported that BD SYRINGE 3ML LL 200 S/C contained foreign matter.Verbatim:complaint via email.On 14Jul2026, during manufacturing a small, black free floating particulate was identified in the product. The particulate was sent out to a third party for identification which determined that it was polypropylene with silicone (see attached). After review of all the components used in the manufacturing process up to the point where the particulate was found, determined that several different syringes were used in the process (see below) which are comprised of polypropylene and silicone. x would like to request an investigation into these three lots of syringes to determine if there were any issues during manufacturing, along with controls in place to prevent particulate contamination of the syringes specifically polypropylene and/or silicone.Please let me know if there are any questionsRegards:NVS SAP Material: 5004641.NVS SAP Batch: MP0018.Vendor: 50085232 / Becton Dickinson.Vendor Material #: 309657.Vendor Batch: 4285707.Expiry: 30Sep2029.PO # (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899354 ↗MalfunctionSep 22, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860022 ↗MalfunctionSep 22, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860020 ↗MalfunctionSep 22, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858515 ↗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 ↗
Other Becton, Dickinson And Company products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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