BD Luer-Lok 309657Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,266 adverse event reports that list this exact device (DI 30382903096573), received between Oct 17, 2017 and Sep 28, 2026 — classified as 3 injuries, 1,263 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (555 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,266 reports, in the reporter's own words as published by the FDA.

• 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 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 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 50860020 ↗
• MalfunctionSep 15, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775089 ↗
• MalfunctionSep 11, 2026Contamination /Decontamination Problem

  It was reported that BD SYRINGE 3ML LL 200 S/C contained foreign matter.Verbatim:Complaint via email. Email(s) attached.Caller asked to clarify the location of the moisture. Is the moisturenoted in the barrel or package. Caller informed that BD syringecontains a medical grade silicone lubricant. If the moisture is insidethe syringe, it could be the silicone lubricant. If it's in the package,it could be a humidity/temperature issue. Per caller the moisture inthe barrel of the syringe. Advised following instructions given byproduct complaints. Caller requested document stating thematerials of the syringe. Emailed the syringe TDS per request.Caller advised to have customer reach out to us directly at x with questions.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736918 ↗
• MalfunctionSep 8, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676786 ↗
• MalfunctionSep 2, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570998 ↗
• MalfunctionAug 21, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50377787 ↗
• MalfunctionAug 14, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246333 ↗
• MalfunctionAug 12, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225444 ↗
• MalfunctionAug 5, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150029 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C PLUNGER ROD WAS BROKEN/ DAMAGED. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED NURSING STAFF UTILIZED SYRINGES TO INJECT MEDICATION AND THERE WAS MUCH RESISTANCE WITH THE PLUNGER WHICH CAUSED THE PLUNGER TO SNAP IN HALF. NURSING STAFF THEN GRABBED A SECOND SYRINGE AND THE SAME RESISTANCE ISSUE PERSISTED AS WELL AS MEDICATION FLOWING BACK INTO THE SYRINGE. THE INCIDENT HAPPENED ON 4/14; THERE WERE NO INJURIES OR NEGATIVE COMPLICATIONS, AND YES, I CAN SECURE SOME SAMPLES OF THAT LOT NUMBER TO SEND TO YOU. IT WASN'T INDICATED WHAT THE SYRINGE WAS ATTACHED TO AND IT WASN'T INDICATED WHAT MEDICATION WAS USED AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163551 ↗
• MalfunctionMay 8, 2026Volume Accuracy Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C HAD A VOLUMETRIC ACCURACY CONCERN. COMPLAINT VIA EMAIL. THERE SEEMS TO BE TWO VARIATIONS OF 3ML LL SYRINGE PRODUCT CODE 309657. CAN WE ORDER THE VERSION OF THE SYRINGE THAT DOES NOT SAY "PLASTIPAK" ON THE SYRINGE? WE NOTICED THAT ON THE PLASTIPAK SYRINGES SOME OF OUR DRUGS ARE GETTING STUCK ON THE SYRINGE. WE DON'T HAVE THAT PROBLEM WITH THE SYRINGES THAT DON'T SAY "PLASTIPAK". WE ARE WORKING WITH NUCLEAR MEDICINE, AND ONE RADIOACTIVE DRUG GETS "VERY STICKY" IN THE SYRINGE THAT SAYS PLASTIPAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128798 ↗
• MalfunctionMay 8, 2026Volume Accuracy Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C HAD A VOLUMETRIC ACCURACY CONCERN. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THERE SEEMS TO BE TWO VARIATIONS OF 3ML LL SYRINGE PRODUCT CODE 309657. CAN WE ORDER THE VERSION OF THE SYRINGE THAT DOES NOT SAY "PLASTIPAK" ON THE SYRINGE? WE NOTICED THAT ON THE PLASTIPAK SYRINGES SOME OF OUR DRUGS ARE GETTING STUCK ON THE SYRINGE. WE DON'T HAVE THAT PROBLEM WITH THE SYRINGES THAT DON'T SAY "PLASTIPAK". WE ARE WORKING WITH NUCLEAR MEDICINE, AND ONE RADIOACTIVE DRUG GETS "VERY STICKY" IN THE SYRINGE THAT SAYS PLASTIPAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127823 ↗
• MalfunctionMay 8, 2026Material Deformation

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 25125079 ↗
• MalfunctionMay 8, 2026Material Deformation

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 25124984 ↗
• MalfunctionMay 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ON 13APR2026 DURING INCOMING AQL INSPECTION, OUT OF THE 315 UNITS SAMPLED, PER THE AQL INSPECTION REQUIREMENT, 3 UNITS WERE OBSERVED TO HAVE VISIBLE PARTICULATE MATTER INSIDE THE PRODUCT (CRITICAL), AND 1 UNIT WAS OBSERVED TO HAVE VISIBLE PARTICULATE MATTER INSIDE THE PACKAGING BUT OUTSIDE THE PRODUCT (MAJOR) (SEE ATTACHED PICTURES). PLEASE PERFORM AN INVESTIGATION TO DETERMINE THE CAUSE OF THE FOREIGN MATTER. THE IMPACTED UNITS ARE AVAILABLE FOR RETURN UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114005 ↗
• MalfunctionMay 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C CONTAINED FOREIGN MATTER. VERBATIM: WE FOUND SOME BLACK MARKS ON PLASTIPACK 3 ML SYRINGES FOR LOT # 5255908. THESE MARKS APPEAR TO BE ON THE SYRINGE BODY ITSELF. WE REQUIRE THESE TO BE STERILE AND UNCONTAMINATED, AS THESE ARE USED FOR DRUG TRANSFER. THEREFORE, THIS IS CONSIDERED TO POTENTIALLY BE A SIGNIFICANT NONCONFORMANCE ON OUR END. AS WE DO NOT OWN THE DESIGN FOR THESE SYRINGES, WE ARE UNABLE TO PLEASE LET ME KNOW WHAT : WHAT THIS MATERIAL IS. WE CAN RETURN ALL DEFECTS TO BD FOR INVESTIGATION. WHETHER OR NOT THIS AFFECTS FORM-FIT-FUNCTION OF THE SYRINGE, SPECIFICALLY SURROUNDING STERILIZATION AND FLUID PATHWAY IMPACT. IF BD CAN SHARE THE RISK PROFILE IDENTIFIED FROM THE INVESTIGATION OF THIS DEFECT, SO THAT WE MAY RETAIN TRACEABILITY OF THIS TO OUR OWN IMPACTED PRODUCT. ADDITIONAL INFORMATION: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2026. KINDLY PROVIDE THE NUMBER OF PRODUCTS AFFECTED BY THIS ISSUE. AT THIS TIME, THE ENTIRETY OF BATCH 5255908 SENT TO US IS IMPLICATED. THE SPECIFIC TOTAL QUANTITY IMPLICATED FROM THIS BATCH IS UNKNOWN, AS WE ONLY IDENTIFIED THIS ISSUE BY CHANCE DURING THE MIDDLE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114004 ↗
• MalfunctionMay 4, 2026Crack

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C BARREL CRACKED. COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION. ALBERTA MDIP REFERENCE NUMBER (ID) (B)(4). DATE OF INCIDENT (YYYY-MM-DD): ON (B)(6) 2026. TYPE OF INCIDENT/PROBLEM A1. DEFECT (OBSERVED PRIOR TO USE). LEVEL OF HARM HAZARD. ALBERTA OPTIONAL REPORT TO CMDSNET (HEALTH CANADA). INCIDENT DETAILS NURSE WAS INJECTING SW INTO THE CATHFLO VIAL TO RECONSTITUTE THE MEDICATION. WHEN THE NURSE DEPRESSED THE PLUNGER, SW SPRAYED OUT FROM THE SIDE OF THE SYRINGE. UPON INSPECTION OF THE SYRINGE, A CRACK APPROXIMATELY 1 INCH IN LENGTH NOTED LENGTH WISE ON THE SYRINGE. AS THERE WAS SOME SW IN THE VIAL, BUT SOME HAD ALSO SPRAYED OUT, NURSE WAS UNSURE EXACTLY HOW MUCH WAS IN THE VIAL, AND THE VIAL OF CATHFLO HAD TO BE WASTED. DEVICE INFORMATION. DEVICE NAME/DESCRIPTION SYRINGE LUER LOCK TIP 3ML. MANUFACTURE BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL 309657. SERIAL OR LOT NUMBER UNKNOWN. SUPPLIER (B)(4), SUPPLIER/CATALOGUE NUMBER 308-309657. IS THE DEVICE RETAINED? YES. NUMBER OF DEVICES 1. WIPED, CONTAINED, LABELLED? DEVICE WAS CLEAN OR NOT USED. INVESTIGATION REQUEST. EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED. E-MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069301 ↗
• MalfunctionApr 17, 2026Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C CONTAINED FOREIGN MATTER. VERBATIM: PLEASE EMAIL OUR BD REP CONCERNING BELOW: "ONE STAFF MEMBER NOTICED THAT SOME SYRINGES HAVE A SLICK, COATING-LIKE FEEL ON THE OUTSIDE AFTER OPENING. WHEN I CHECKED, I OBSERVED THE SAME THING. THIS COATING PREVENTS THE MEDICATION LABELS FROM STICKING PROPERLY. THIS COULD POSE A SAFETY RISK FOR MEDICATIONS THAT REQUIRE CLEAR LABELING. SYRINGES APPEAR TO BE FROM THE SAME LOT (SEE IMAGE).".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916398 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C PLUNGER ROD WAS BROKEN/DAMAGED. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED COMPLAINT REFERENCE #: (B)(4). COMPLAINT REFERENCE #: (B)(4). CUSTOMER (HOSPITAL) NAME: X CUSTOMER ADDRESS: X CONTACT NAME: X PHONE: X E-MAIL: X CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: BD309657 DESCRIPTION OF PRODUCT: SYRINGE LL TIP ST 3CC (B)(4) /BX 4BX/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE INCIDENT DATE: 19 MAR 2026 HOSPITAL COMPLAINT REFERENCE #: (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): THE PLUNGER OF THIS SYRINGE IS PRONE TO DEFORMATION. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS X BEEN INFORMED? UNKNOWN QTY AFFECTED: (B)(4) EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY:.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845648 ↗
• MalfunctionApr 1, 2026Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C LABEL CONTENT WAS INCORRECT. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS IS THE OFFICIAL REQUEST FOR INVESTIGATION FOR NON-CONFORMANCE: NC-(B)(4). NC NUMBER NC-(B)(4). CAPA/ACT NUMBER ACT-064862. MM# 10500500 3 ML SYRINGE SUPPLIER MATERIAL (CATALOG) PART NUMBER 309657 SUPPLIER BD PLASTICS IS THE MATERIAL BOUGHT DIRECTLY FROM SUPPLIER? NO THIS IS PURCHASED THROUGH (B)(6). PO NUMBER (B)(4). SUPPLIER LOT NUMBER 5133990 COC OR COA OF THE IMPACTED MATERIAL N/A SUMMARY OF THE DEFECT BASED ON THE NC CONCLUSION (FAILURE MODE / WHEN, WHO, WHERE, HOW, WHAT) DESCRIPTION OF ISSUE: APN-044452: INITIATE THE SUPPLIER INVESTIGATION FOR A MISLABELED CONTAINER OF 3ML SYRINGES SHIPPED FROM TO PRINCE STERILIZATION. ONE CARTON FROM THE MASTER PACK WAS LABELED AS 5 ML, HOWEVER, THE INNER CONTAINER CONTAINED 3 ML SYRINGES AND CONTAINED ONLY 125 QUANTITIES INSTEAD OF 200. IS THE AFFECTED MATERIAL AVAILABLE NO: THEY WERE DISPOSITIONED AS SCRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761541 ↗
• MalfunctionMar 20, 2026Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650255 ↗

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, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 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 · Terminated
  BD 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-2752-2017 · Sep 16, 2016 · Terminated
  BD 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-2749-2017 · Sep 16, 2016 · Terminated
  BD 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-2753-2017 · Sep 16, 2016 · Terminated
  BD 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 · Terminated
  BD 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-1937-2016 · Mar 25, 2016 · Terminated
  Henry 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 · Terminated
  Henry 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 · Terminated
  BD 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