BD Luer-Lok 309702Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 3ML LL TIP BULK CONVENIENCE PAK · Class 2
All models of BD Luer-Lok (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Luer-Lok syringe has 147 FDA adverse event reports, with no deaths and no injuries. All are logged as malfunctions. Many describe contamination, such as particles found inside the syringe, while others mention leaks and cracks. Patients were mostly reported with no clinical signs. 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
- 148
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 30382903097020), received between Oct 30, 2017 and Aug 19, 2026 — classified as 148 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (35 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. 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
- Device Contamination with Chemical or Other Material35
- Leak/Splash25
- Contamination /Decontamination Problem23
- Device Markings/Labelling Problem10
- Crack8
- Packaging Problem8
- Defective Component7
- Fluid/Blood Leak7
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- No Known Impact Or Consequence To Patient45
- No Patient Involvement9
- No Consequences Or Impact To Patient8
- No Information4
Recent adverse event reports
The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327076 ↗MalfunctionAug 19, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327075 ↗MalfunctionAug 19, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327070 ↗MalfunctionAug 5, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145469 ↗MalfunctionApr 17, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. DMR # (B)(4) PO #: (B)(4) DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 3ML BD 25PK (REF. 309702) LOT NUMBER: 5331880 ITEM CODE: 309702 DEFECTIVE QUANTITY:1. DEFECT DESCRIPTION: PARTICULATE FOUND IN 3ML BD SYRINGE. FTIR WAS DESTRUCTIVE TESTING. THE FTIR ANALYSIS CAME BACK AS CARDBOARD. SAMPLE NOT AVAILABLE TO BE RETURNED. OBSERVED DATE: (B)(6) 2026 OBSERVED DURING WHICH PROCESS STAGE: ILP. IR/ DMI NUMBER IF LAUNCHED: (B)(4) SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: NO IS DEFECTIVE EVIDENCE (I.E. PICTURES, TEST RESULTS ETC.) AVAILABLE? YES IS PATIENT IMPACTED? NO IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO IF THE DEFECT REPORT FROM QUVA CUSTOMER? NO IS THERE A TREND OBSERVED? NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915765 ↗MalfunctionMar 23, 2026Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663550 ↗MalfunctionMar 23, 2026Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER THAT OBSERVED A PARTICLE INSIDE A 3 ML SYRINGE DURING VISUAL INSPECTION. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE WOULD LIKE TO FILE A PRODUCT COMPLAINT FOR A PARTICLE IN A 3 ML SYRINGE. DATE OF THE EVENT: 03/05/2026. HOW MANY ITEMS WERE AFFECTED PER LOT? 1. IS THE PRODUCT AVAILABLE TO BE RETURNED FOR INVESTIGATION? NO, SYRINGE SAVED FOR INTERNAL PRODUCT VISUAL INSPECTION LIBRARY. HOW MANY ITEMS ARE AVAILABLE TO RETURN? 0. OUR INTEGRADOSE REFERENCE NUMBER IS: (B)(4). ON 03/05/2026, DURING PRODUCTION USING THE 3 ML SYRINGES, PN 309702, TECHNICIANS OBSERVED A PARTICLE INSIDE A 3 ML SYRINGE DURING VISUAL INSPECTION. THE MAJORITY OF SYRINGES USED WERE FROM LOT# 5339733; HOWEVER, SINCE UNITS FROM OTHER LOTS WERE USED, IT IS NOT POSSIBLE TO SPECIFY A SINGLE LOT. STAFF HAS IDENTIFIED THIS PARTICLE AS ¿JAGGED, PLASTIC SLIVER.¿ THIS PARTICLE IS SIMILAR TO THOSE WE¿VE BEEN SEEING AT INTEGRADOSE. ADDITIONAL INFORMATION RECEIVED ON 9-MAR-2026: NO PATIENT HARM, INJURY OR COMPLICATION OCCURRED AS A RESULT OF THIS EVENT. HOWEVER, INTEGRADOSE HAD TO DISPOSE OF A FULL SYRINGE OF PRODUCT AS THE PARTICLE WAS IDENTIFIED THROUGH OUR VISUAL INSPECTION PROCESS A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663549 ↗MalfunctionMar 23, 2026Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663548 ↗MalfunctionMar 23, 2026Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663547 ↗MalfunctionJan 28, 2026Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201384 ↗MalfunctionJan 26, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER MATERIAL #309702 BATCH #5127598. IT WAS REPORTED BY CUSTOMER THAT FOUND TWO 3ML SYRINGES WITH WHAT WAS IDENTIFIED AS SILICONE ON THEM. RCC RECEIVED A COMPLAINT VIA EMAIL. DMR # PO #: DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 3ML BD 25PK (REF. 309702) LOT NUMBER: 5127598 ITEM CODE: 309702. DEFECTIVE QUANTITIES: 2. DEFECT DESCRIPTION: FOUND TWO 3ML SYRINGES WITH WHAT WAS IDENTIFIED AS SILICONE ON THEM. OBSERVED DATE: (B)(6) 2026. OBSERVED DURING WHICH PROCESS STAGE: COMPOUNDING IR/ DMI NUMBER IF LAUNCHED: SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: NO IS DEFECTIVE EVIDENCE (I.E. PICTURES; TEST RESULTS ETC.) AVAILABLE? YES, IS PATIENT IMPACTED? NO IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO IF THE DEFECT REPORT FROM QUVA CUSTOMER? NO IS THERE A TREND OBSERVED? NO SUPPLIER ACTION AWARENESS/ ATTENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178186 ↗MalfunctionJan 15, 2026Break; Product Quality Problem
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK PLUNGER ROD WAS BROKEN / DAMAGED IT WAS REPORTED BY CUSTOMER THAT THERE WERE 4 SYRINGES FOUND THAT PLUNGER HAD DEFECTS DURING THE SUGAMMADEX. VERBATIM: " I HAVE HAD A COUPLE REPORTS ABOUT SOME WITH DEFECTIVE PLUNGERS"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080085 ↗MalfunctionJan 15, 2026Break; Product Quality Problem
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK PLUNGER ROD WAS BROKEN / DAMAGED IT WAS REPORTED BY CUSTOMER THAT THERE WERE 4 SYRINGES FOUND THAT PLUNGER HAD DEFECTS DURING THE SUGAMMADEX. VERBATIM: " I HAVE HAD A COUPLE REPORTS ABOUT SOME WITH DEFECTIVE PLUNGERS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080084 ↗MalfunctionJan 15, 2026Break; Product Quality Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080077 ↗MalfunctionJan 15, 2026Break; Product Quality Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080076 ↗MalfunctionDec 30, 2025Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924025 ↗MalfunctionDec 30, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT ONE SYRINGE WITH FADED MARKINGS, PLUNGER LEAKING, PLUNGER LEAKING, WARPED PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924022 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923714 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923705 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923704 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD LEAKED IT WAS REPORTED BY THE CUSTOMER THAT ONE SYRINGE WITH FADED MARKINGS, PLUNGER LEAKING, PLUNGER LEAKING, WARPED PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923701 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD LEAKED IT WAS REPORTED BY THE CUSTOMER THAT ONE SYRINGE WITH FADED MARKINGS, PLUNGER LEAKING, PLUNGER LEAKING, WARPED PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923700 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT ONE SYRINGE WITH FADED MARKINGS, PLUNGER LEAKING, PLUNGER LEAKING, WARPED PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923698 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923314 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT ONE SYRINGE WITH FADED MARKINGS, PLUNGER LEAKING, PLUNGER LEAKING, WARPED PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923313 ↗
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-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-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-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-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-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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page