BD Luer-Lok 309703Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 5ML LL TIP BULK CONVENIENCE PAK · Class 2
All models of BD Luer-Lok (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Luer-Lok 5 mL syringe is a piston syringe used to draw up and deliver fluids. All 161 reports are malfunctions, and many describe syringes with foreign particles, leaks, cracks, or unclear markings. The reports include no deaths or injuries. 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
- 165
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 30382903097037), received between Oct 19, 2017 and Sep 30, 2026 — classified as 165 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (49 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash49
- Device Contamination with Chemical or Other Material42
- Device Markings/Labelling Problem18
- Contamination15
- Crack9
- Contamination /Decontamination Problem7
- Volume Accuracy Problem4
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions100
- No Known Impact Or Consequence To Patient45
- No Consequences Or Impact To Patient13
- No Patient Involvement5
- Insufficient Information3
- No Information1
Recent adverse event reports
The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.
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 22, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858515 ↗MalfunctionSep 18, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820943 ↗MalfunctionSep 18, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819862 ↗MalfunctionSep 17, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808567 ↗MalfunctionSep 9, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695177 ↗MalfunctionAug 18, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304768 ↗MalfunctionAug 13, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235664 ↗MalfunctionAug 11, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212156 ↗MalfunctionAug 11, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211063 ↗MalfunctionApr 16, 2026Contamination
IT WAS REPORTED BY A CUSTOMER THAT ONE SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE, AND ONE SYRINGE HAD EXCESSIVELY SLANTED SYRINGE MARKINGS. COMPLAINT VIA EMAIL. ON 03/31/2026, DURING VISUAL INSPECTION OF LOT: 20260325-2668C6, ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) -1, ONE SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE AND ONE SYRINGE HAD EXCESSIVELY SLANTED SYRINGE MARKINGS. THESE UNITS ARE AVAILABLE FOR RETURN. DETAILS FOR YOUR INVESTIGATION: PRODUCT: STERILE SYRINGE TRAY 5ML LOT NUMBER: 5174808/5212183/5218656 PART NUMBER: 309703 NUMBER OF DEFECTIVE UNITS: 2 DEFECT TYPE: FOREIGN PARTICULATE AND DEFECTIVE SYRINGE MARKINGS PRODUCT COMPLAINT: (B)(4) PLEASE LET ME KNOW THE RESULTS OF THE INVESTIGATION ADDITIONAL INFORMATION RECEIVED ON 08APR2026: AS TWO ISSUES HAVE BEEN REPORTED¿FOREIGN MATTER AND A SCALE MARKING ISSUE¿PLEASE CLARIFY WHICH SPECIFIC LOT IS ASSOCIATED WITH EACH ISSUE. THE BATCH/LOT NUMBERS PROVIDED ARE 5174808, 5212183, AND 5218656. WITH THREE DIFFERENT LOTS BEING USED FOR THIS BATCH, WE DO NOT KNOW WHICH LOTS ARE THE ONE WITH DEFECTS. THERE ARE ONLY 2 UNITS WITH DEFECTS. THE NUMBERS I HAD LISTED WERE THE TOTAL AMOUNT WE HAD RECEIVED. AS THE AFFECTED QUANTI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897103 ↗MalfunctionApr 3, 2026Contamination
IT WAS REPORTED BY CUSTOMER THAT THE 1 SYRINGE CONTAINED A FOREIGN PARTICULATE. 1 SYRINGE HAD A LARGE INK SPOT ON THE BARREL. 1 SYRINGE HAD A CRACK ON THE BASE OF THE BARREL. 4 SYRINGES HAD LARGE PIECES OF PLASTIC BROKEN OFF OF THE PLUNGERS. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ON (B)(6) 2026 DURING COMPOUNDING AND ON (B)(6) 2026 DURING VISUAL INSPECTION OF LOT 20260317 33FB47 ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) SEVERAL DEFECTS WERE DISCOVERED. 1 SYRINGE CONTAINED A FOREIGN PARTICULATE. 1 SYRINGE HAD A LARGE INK SPOT ON THE BARREL. 1 SYRINGE HAD A CRACK ON THE BASE OF THE BARREL. 4 SYRINGES HAD LARGE PIECES OF PLASTIC BROKEN OFF OF THE PLUNGERS. THE UNIT CONTAINING A FOREIGN PARTICULATE IS AVAILABLE FOR RETURN. DETAILS FOR YOUR INVESTIGATION: PRODUCT: STERILE SYRINGE TRAY 5ML LOT NUMBER: 5174810 PART NUMBER: 309703 NUMBER OF DEFECTIVE UNITS: 7 DEFECT TYPE: FOREIGN PARTICULATE. INK SOT ON BARREL. CRACK ON BASE OF BARREL. LARGE PLASTIC PIECES OF PLASTIC BROKEN OFF PLUNGER. PRODUCT COMPLAINT: (B)(4) QUANTITY: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781045 ↗MalfunctionFeb 2, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT BLACK PARTICLES FOUND ON SYRINGE - PARTICULATE UNDER THE PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(4). DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 5ML BD 25PK (REF. 309703) LOT NUMBER: 5245945 ITEM CODE: 309703 DEFECTIVE QUANTITY: (B)(4) DEFECT DESCRIPTION: BLACK PARTICLES FOUND ON SYRINGE - PARTICULATE UNDER THE PLUNGER. OBSERVED DATE: (B)(6) 2025 OBSERVED DURING WHICH PROCESS STAGE: ILP 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 24234622 ↗MalfunctionJan 20, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT THE BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL# 309703, BATCH#: 5218660. RCC RECEIVED A COMPLAINT VIA EMAIL. DMR#: 625 PO#: (B)(4), DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 5ML BD 25PK (REF. 309703), LOT NUMBER: 5218860, ITEM CODE: 309703, DEFECTIVE QUANTITY: 1, DEFECT DESCRIPTION: 1 UNIT HAD A TAN TO BROWN PARTICULATE THAT WAS CLASSIFIED AS ¿INTRINSIC TO BD¿S MANUFACTURING PROCESS, OBSERVED DATE: NOVEMBER 4, 2025, OBSERVED DURING WHICH PROCESS STAGE: ILP, IR/ DMI NUMBER IF LAUNCHED: DEV-04106, 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. ADDITIONAL INFORMATION: DATE OF EVENT: 4 NOVEMBER 2025, LOT NUMBER: 5218660.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24125935 ↗MalfunctionDec 30, 2025Crack; Crack
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924287 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK LEAKED IT WAS REPORTED BY THE CUSTOMER THAT SYRINGE BARREL DENTED AND CRACKED, PLUNGER LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924285 ↗MalfunctionDec 30, 2025Product Quality Problem; Product Quality Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924023 ↗MalfunctionDec 17, 2025Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK LEAKAGE IT WAS REPORTED BY CUSTOMER THAT THE SEVERAL SYRINGES IN THIS BATCH LEAK AT THE PLUNGER. THEY ARE NOT AIRTIGHT AND ARE THEREFORE NO LONGER STERILE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CAT# OF PRODUCT BEING COMPLAINED: BD309703 DESCRIPTION OF PRODUCT: SYRINGE TRAY 5ML LL ST SP=PK 25EA/PK 12PK/CA LOT OR S/N(B)(6) COMPLAINT CATEGORY: LEAKING REPORTABLE: NO INCIDENT DATE: (B)(6) 1980 DETAILS OF COMPLAINT (REPORTED ISSUE): SEVERAL SYRINGES IN THIS BATCH LEAKED AT THE PLUNGER. ADDITIONAL INFORMATION WILL BE SENT VIA SEPARATE EMAIL. PLEASE NOTE: INCIDENT DATE UNKNOWN. SEVERAL SYRINGES IN THIS BATCH LEAK AT THE PLUNGER; THEY ARE NOT AIRTIGHT AND ARE THEREFORE NO LONGER STERILE. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO QTY AFFECTED: 1 PK SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA? NO CUSTOMER RESPONSE ON 11-DEC-2025. 1. PLEASE CONFIRM IF THE PISTON IS DAMAGED OR IMPROPERLY FITTED? NO TO MY VISUAL ANALYSIS 2. WAS THE LEAK CAUSED BY DAMAGE TO THE PISTON? NO TO MY VISUAL ANALYSIS IF WE LOOK CLOSELY AT THE IMAGE, WE SEE LIQU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828735 ↗MalfunctionDec 10, 2025Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION: IT IS INDEED 33 SYRINGES FROM A BATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768634 ↗MalfunctionNov 30, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677045 ↗MalfunctionNov 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600904 ↗MalfunctionOct 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348484 ↗MalfunctionOct 15, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295871 ↗MalfunctionAug 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905091 ↗MalfunctionAug 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874234 ↗
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-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-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-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-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-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-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 18, 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