BD Luer-Lok 309578Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30382903095781), received between Feb 12, 2018 and Jan 19, 2023 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE THE STOPPER SEPARATED FROM THE PLUNGER. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTING THE RUBBER IS COMING OFF OF THE SYRINGE PLUNGER AND CAUSING AIR TO BE DRAWN IN. TWO WERE FOUND IN THIS LOT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16211806 ↗
• MalfunctionNov 22, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED BD LUER-LOK¿ SYRINGE WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECENTLY FOUND TROUBLE WITH A SPECIFIC LOT OF SYRINGES... WHERE THE SYRINGES HAVE A CRACK IN THEM. THIS IS DANGEROUS, AS WE FOUND WHEN A CRACK IN A SYRINGE CAUSED SOME MEDICATION TO SPRAY OUT...".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857501 ↗
• MalfunctionJan 19, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 20X1 RB PLUNGER WAS LOOSE AND DISPENSED MEDICATION INTO THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FRIDAY, (B)(6) 2020 A BD 3 ML SYRINGE (LOT # 0224675) MALFUNCTIONED - ALLOWING THE PLUNGER TO RISE AND DISPENSE MEDICATION INTO THE CAP. THE NEEDLE THAT WAS ATTACHED WAS LOT # 200821B. THIS MALFUNCTION RESULTED IN THE NEED TO WASTE 40,000 UNITS OF PROCRIT (LOT # G 477168A)] NOBODY WAS INJURED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11198422 ↗
• MalfunctionJun 9, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 3ML SYRINGE LUER-LOK¿ TIPS WITH BD PRECISION GLIDE¿ NEEDLES EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309578 BATCH NO: UNKNOWN. CALLER ASKING FOR EXPIRATION DATE/SHELF LIFE FOR SYRINGE# 309578. CALLER STATES THERE ARE NO MARKINGS ON THE SYRINGE PACKAGE. ASKED CALLER IF THERE IS A DATE OR HOURGLASS MARKING ON PACKAGE. THE SHELF LIFE FOR ALL BD SYRINGES IS 5 YEARS FROM DATE OF MANUFACTURE. SOME BD PRODUCTS DO NOT HAVE AN EXPIRATION DATE ON THE PACKAGING. THE FDA DOES NOT REQUIRE DATING ON ALL PRODUCTS. WE CANNOT RECOMMEND USING PRODUCTS PAST EXPIRATION DATES. OFFERED CALLER TO SEND ME PICTURE OF PACKAGING AND CALLER DECLINED. ASKED CALLER IF SHE HAS ADDITIONAL PRODUCT NUMBERS AND SHE CONFIRMS SHE HAS SIX BOXES OF SYRINGES WITH DIFFERENT PRODUCT NUMBERS. ASKED CALLER TO SEND EMAIL TO [email protected] AND LIST THE PRODUCT NUMBERS AND IF THERE ARE ANY MARKINGS OR DATES ON THE PACKAGING AND WE WILL ASSIST HER. CALLER DECLINED AND STATES SHE WILL CALL CUSTOMER SERVICE AGAIN AS SHE DOES NOT NEED THAT DETAILED OF INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 10134184 ↗
• InjuryJan 14, 2020Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL 20X1 RB WERE INVOLVED IN SERIOUS INJURIES IN THE FORM OF MEDICAL CONSULTATION RESULTING FROM A POTENTIAL BREACH IN STERILITY WHICH WAS NOTED AFTER USE. IT HAS BEEN STATED THAT MULTIPLE DEVICES WERE USED BY THE MEDICAL DEVICE OPERATOR AFTER A POTENTIAL STERILITY BREACH IN THE DEVICE PACKAGING, RESULTING IN "INFECTION EACH TIME." THIS HAS RESULTED IN A REVIEW OF THE USER FACILITY'S PROCEDURES, AND AN UNSPECIFIED NUMBER OF THE PATIENT'S RECEIPT OF ADDITIONAL MEDICAL CONSULTATION/TREATMENT. THE RESULTS OF THIS ADDITIONAL MEDICAL CONSULTATION/TREATMENT HAVE NOT BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309578 BATCH NO: UNKNOWN. EVENT DESCRIPTION: DISTRIBUTOR HAS A CUSTOMER THAT USES THE 3ML SYRINGE/NEEDLE 309578. HE WANTS TO KNOW IF THE SYRINGES ARE STILL STERILE ONCE THE BOX IS OPENED. HE USES ONE EVERY FEW DAYS TO ADMINISTER A MEDICATION AND REPORTS GETTING AN INFECTION EACH TIME. RESPONSE WITH ADDITIONAL INFORMATION: INFORMED THAT THE NEEDLE AND INSIDE OF THE SYRINGE WILL REMAIN STERILE UNTIL USED OR UNTIL THE CAP IS REMOVED. RECOMMENDED HE CONTACT HIS NURSE OR PHYSIC

  Patient problems: Unspecified Infection

  MAUDE report 9587726 ↗
• MalfunctionNov 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT HAS BEEN REPORTED THAT ONE SYRINGE 3ML LL W/NDL 20X1 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PRIOR TO INJECTING GLYCOPYRROLATE THE NURSE HAD TROUBLE PUSHING THE MEDICINE TROUGH AND HAD TO HAVE THE DOCTOR ON DUTY REMOVE THE SYRINGE FROM THE NEEDLE AND THAT'S WHEN A FOREIGN SUBSTANCE WAS NOTICED IN THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9292846 ↗
• MalfunctionOct 15, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 3ML LL W/NDL 20X1 RB EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER, WHILE ANOTHER EXPERIENCED STOPPER DEFORMATION/DAMAGE. BOTH DEFECTS WERE NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309578 BATCH NO: 9037866 & 9044707. CUSTOMER REPORTED: RN WAS DRAWING UP A DOSE AND THE SYRINGE HAD A FAULTY RUBBER STOPPER. BEGAN RUNNING OUT OF SYRINGE SO WE LOST THE DOSE . THE NURSES TELL ME THIS IS THE SECOND FAULTY SYRINGE IS A FEW WEEKS SO THEY ARE NOW REALLY WATCHING WHEN THEY REMOVE THEM FROM THEIR SEALED PLASTIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9193878 ↗
• MalfunctionOct 15, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO SYRINGES 3ML LL W/NDL 20X1 RB EXPERIENCED LEAKAGE PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309578 BATCH NO: 9037866 & 9044707. CUSTOMER REPORTED: I DON¿T THINK I HAVE HAD THIS HAPPEN BEFORE, RN WAS DRAWING UP A DOSE AND THE SYRINGE HAD A FAULTY RUBBER STOPPER. MEDICATION BEGAN RUNNING OUT OF SYRINGE SO WE LOST THE DOSE . THE NURSES TELL ME THIS IS THE SECOND FAULTY SYRINGE IS A FEW WEEKS SO THEY ARE NOW REALLY WATCHING WHEN THEY REMOVE THEM FROM THEIR SEALED PLASTIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9193108 ↗
• MalfunctionJul 25, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKING ERROR WAS FOUND BEFORE USE WITH SYRINGES 3ML LL W/NDL 20X1 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE MEASUREMENT MARKINGS ARE OFF ON THIS BATCH OF SYRINGES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8828152 ↗
• MalfunctionJun 24, 2019Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE W/ PRECISIONGLIDE¿ NEEDLE HAD SCALE MARKING ISSUES AND FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309578 BATCH NO: UNKNOWN IT WAS REPORTED THAT GRADUATION MARKS DO NOT STICK WELL AND SURFACE OF BARREL IS WAXY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8728482 ↗
• MalfunctionApr 30, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES WITH A BD SYRINGE 3ML LL¿ W/NDL 20X1 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE MEASUREMENTS ON THE SYRINGE ARE INCORRECT. DETAILS OF COMPLAINT (REPORTED ISSUE): IDENTIFICATION MEASUREMENT IS INCORRECT A CAN LEAD TO DANGER OF WRONG DOSAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8566221 ↗
• MalfunctionNov 20, 2018Contamination /Decontamination Problem

  IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8092032 ↗
• MalfunctionSep 24, 2018Device Markings/Labelling Problem

  IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH SCALE MARKING ERROR. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903477 ↗
• MalfunctionJun 7, 2018Split

  IT WAS REPORTED THAT DURING USE, A BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE ¿SPLIT¿ WHEN ATTEMPTING TO ADMINISTER MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579821 ↗
• MalfunctionMar 11, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE LEAKED RADIOACTIVE FLUID DOWN THE SIDE OF THE BARREL THROUGH A CRACK. THERE WAS NO REPORTS OF EXPOSURE OR SERIOUS INJURY. NO MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7329890 ↗
• MalfunctionMar 5, 2018Crack; Structural Problem

  IT WAS REPORTED THAT WITH USE, FIVE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLES WERE FOUND BROKEN AS A CRACK WAS FOUND IN THE BARREL. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7314872 ↗
• MalfunctionFeb 12, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT NORMAL SALINE LEAKED FROM A SMALL CRACK IN THE BARREL OF A BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7263595 ↗

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-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-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-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-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-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-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-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