BD Luer-Lok 309644Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00382903096442), received between Mar 16, 2018 and Apr 3, 2023 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD A HOLE IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT: A USER FACILITY¿S FACILITY ADMINISTRATOR REPORTED THAT A 10CC SYRINGE LUER LOK 20GX1 DETACHABLE HAD A HOLD IN THE PLASTIC SYRINGE. THERE WAS NO PATIENT INVOLVEMENT, HARM, OR ADVERSE EVENT REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663942 ↗
• MalfunctionDec 13, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE LUER-LOK SYRINGE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A HEMODIALYSIS (HD) CLINIC NURSE REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY HAD MULTIPLE CRACKED CASINGS OF LUERLOK TIP PRECISION GLIDE NEEDLES, SOME FOUND BEFORE USE, SOME DURING PRIMING, AND SOME DURING USE THAT COULD EASILY SPRAY FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973381 ↗
• MalfunctionOct 1, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED WHILE USING BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ A CRACK IN THE SYRINGE CAUSED BLOOD LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A USER FACILITY CLINIC MANAGER REPORTED TO CUSTOMER SERVICE THAT THERE WERE CRACKS IN THE BARREL OF THE SYRINGE DUE TO A POTENTIAL LOOSE SEAL AND CAUSING CONTENTS/BLOOD TO SQUIRT OUT WHEN PUSHING CONTENTS IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524638 ↗
• MalfunctionSep 30, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BARREL OF THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WAS CRACKED AND LEAKED BLOOD/SOLUTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A USER FACILITY CLINIC MANAGER REPORTED TO CUSTOMER SERVICE THAT THERE WERE CRACKS IN THE BARREL OF THE SYRINGE DUE TO A POTENTIAL LOOSE SEAL AND CAUSING CONTENTS/BLOOD TO SQUIRT OUT WHEN PUSHING CONTENTS IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520666 ↗
• MalfunctionApr 14, 2022Contamination; Contamination

  IT WAS REPORTED WHILE USING BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE THE NEEDLE PENETRATED THROUGH THE SHIELD AND PUNCTURED A WORKER'S FINGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF EVENT- (B)(6) 2022. ONE OF OUR PHYSICIANS STUCK THEMSELVES TODAY WITH ONE OF THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110356 ↗
• MalfunctionJul 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LL W/NDL 20X1 RB NEEDLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE BENT AND STUCK STAFF MEMBER WHILE ATTEMPTING TO DRAW UP MEDICATION. CUSTOMER RESPONSE: DID THE STAFF MEMBER REQUIRE ANY MEDICAL INTERVENTION? NO. WHAT WAS THE DATE OF THE EVENT? ON (B)(6) 2021.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12194014 ↗
• MalfunctionJun 23, 2021Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT A SYRINGE 10ML LL W/NDL 20X1 RB WAS FOUND TO HAVE MOLD PRESENCE BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "A REGISTERED NURSE (RN) CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT ONE SYRINGE IN THE MIDDLE OF THE BOX IS GROWING MOLD. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM, OR ADVERSE EVENT REPORTED AT INTAKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054555 ↗
• MalfunctionJun 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED BD INTIMA II LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE PATIENT WAS TREATED IN THE HOSPITAL BECAUSE OF ABNORMAL UTERINE BLEEDING. DURING THE TREATMENT, AN INDWELLING NEEDLE WAS USED FOR THE PATIENT. DURING THE NORMAL INDWELLING PERIOD, THE FLUID WAS LEAKED, SO THE NEEDLE WAS REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045867 ↗
• MalfunctionAug 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 10 ML BD LUER-LOK¿ SYRINGES WITH BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. (B)(6) BATCH NO. 9346089. A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THAT THEY ARE HAVING ISSUES WITH THE LUER LOK SYRINGE. WHEN THEY PULL THE CAP OFF, THE NEEDLE COMES OFF ALONG WITH THE CAP SO SHE HAS TO HOLD THE BOTTOM PART. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AT INTAKE.

  Patient problems: No Patient Involvement

  MAUDE report 10370266 ↗
• MalfunctionMay 19, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE LEAKED AROUND THE HUB DURING USE WHILE DRAWING UP MEDICATION. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST CALLED ON BEHALF ON CONSUMER, STATED WHEN THE CONSUMER WAS DRAWING HIS MEDICATION, HE NOTICED LEAKAGE AROUND THE HUB. STATED, THE PATIENT WAS NOT ABLE TO USE THE SYRINGES 2 SYRINGES AFFECTED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10070247 ↗
• MalfunctionMar 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL W/NDL 20X1 RB EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309644 BATCH NO.: 4139688. CLARIFICATION: UPON SPEAKING WITH THE CUSTOMER, HE REPORTED THE BOX WAS RIPPED, SYRINGES WERE MISSING AND THERE WAS A BIG BLUE STICKER ON THE BOX. HE COULD NOT DETERMINE IF THE BOX CAME FROM A DISTRIBUTOR OR BD THAT WAY. HE STATES HE STILL HAS THE BOX AND WILL RETURN FOR INVESTIGATION. VERBATIM: A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED TO CUSTOMER SERVICE THAT WHEN THEY TOOK THE SYRINGE OUT OF THE BOX IT WAS BROKEN IN THE WRAP. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM OR ADVERSE EVENT REPORTED AT INTAKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806101 ↗
• MalfunctionDec 10, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL NO. 309644 BATCH NO. 7210934. IT WAS REPORTED THAT AFTER USE OF THE 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE AN EXPIRED NEEDLE WAS USED FOR TWO WEEKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CONTACT FOR PERITONEAL DIALYSIS PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THAT THE PATIENT WAS UNAWARE AND WAS USING THE EXPIRED NEEDLE FOR THE LAST 2 WEEKS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9448973 ↗
• MalfunctionNov 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD AN OILY SUBSTANCE IN THE SYRINGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309644 BATCH NO.: 8339540, 9025642, UNKNOWN IT WAS REPORTED BY THE CONSUMER THAT AN "OILY SUBSTANCE" WAS FOUND IN THE BARREL OF THE SYRINGES NEAR THE STOPPER. CONSUMER REPORTED, SEEING A "OILY SUBSTANCE" IN BARREL OF SYRINGES, NEAR THE STOPPER. STATED, SHE'S FINDING "GLOBS" OF "OILY SUBSTANCE". SHE'S NOT ABLE TO USE THE SYRINGES. SAME ITEM/REF NUMBERS FOR ALL THREE BOXES. SHE PROVIDED HOME ADDRESS AND PHARMACY ADDRESS TO SEND REPLACEMENT. CUSTOMER CALLED IN AND WANTED TO REPORT THAT 80% OF THE LAST 3 BOXES SHE RECEIVED HAS OILY SUBSTANCE ON THE PLUNGER FOR THE 10ML SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9294341 ↗
• MalfunctionJun 28, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKING ISSUE WERE FOUND DURING USE WITH A 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, . "GLUE PISTON - DOUBTS ABOUT THE RELIABILITY OF GRADUATION - SQUEEGEE DOES NOT GLUE PROPERLY (SURFACE IS AS A CIREUSE BUT IT IS INTERMITTING HANDLING NOT WELL DECREASED SPEED OF DRUG ADMINISTRATION NURSE SAYS THAT WHEN IT TAKES A MEDICINE THERE IS SOME QUANTITY WHEREAS IT DOES NOT ARRIVE BEFORE, IS NOT UNTIL A NON-IDENTIFIER DRUG (TIGHTENING STICK) RESUTE TO A GASPILLE OF MEDICINE / LOSS OF TIME / RISK OF ERROR ( I DO NOT HAVE THE TOTAL QUANTITIES AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8744321 ↗
• MalfunctionMar 19, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING USE OF THE 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WHEN MIXING DRUG CLINICIAN DISCOVERED WHAT LOOKED TO BE A PIECE OF THE PLUNGER HANGING INSIDE THE SYRINGE WHILE MIXING THE DRUG. THERE WERE TWO OCCURRENCE. THIS COMPLAINT IS CAPTURING THE FOREIGN MATTER FOR THE 10ML SYRINGE'S. PER DESCRIPTION ON INCIDENT FORM: 20ML SYRINGE, ITEM # 30283,0 LOT: 8332972. THIS ONE HAS GREASE ON THE OUTSIDE OF THE SYRINGE. WE ALSO HAD A 10ML WITH GREASE DOWN IN WHERE THE NEEDLE SCREWS IN AND IT LOOKS LIKE A BLACK FUZZ AND ANOTHER 20ML THAT HAD GREASE INSIDE THE SYRINGE WHERE THE BARREL IS. BUT WE DO NOT HAVE THE LOT # FOE THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433277 ↗
• MalfunctionFeb 15, 2019Corroded

  IT WAS REPORTED THAT BEFORE USE OF THE 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE THAT A RUST COLORATION WAS NOTICED BETWEEN THE THREADS OF THE SYRINGE AND IN THE BARREL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8345367 ↗
• MalfunctionJan 31, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE APPEARED TO HAVE "RUST-COLORED MATERIAL / CONTAMINATION" BETWEEN THE "THREADS" OF THE SYRINGE, AS WELL AS IN THE BARREL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8294470 ↗
• MalfunctionJan 7, 2019Peeled/Delaminated

  IT WAS REPORTED THAT A 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE WAS COVERED WITH PLASTIC SHAVINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224195 ↗
• MalfunctionDec 19, 2018Unsealed Device Packaging

  IT WAS REPORTED THAT A 10 ML BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WAS NOT COMPLETELY SEALED.

  Patient problems: No Information

  MAUDE report 8180213 ↗
• MalfunctionDec 13, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE WAS CONTAMINATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161908 ↗
• MalfunctionSep 20, 2018Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT A BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD WHITE RESIDUE ON IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894456 ↗
• MalfunctionMay 11, 2018Break

  IT WAS REPORTED THE HUBS "YELLOW CONNECTOR" WERE FOUND BROKEN ON BD LUER-LOK¿ SYRINGES WITH BD PRECISIONGLIDE¿ NEEDLES PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7507846 ↗
• MalfunctionApr 2, 2018Detachment Of Device Component

  IT WAS REPORTED DURING USE OF THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE ¿THE CLINICAL MANAGER REPORTED THAT WHEN THE BD SYRINGE NEEDLE WAS INSERTED INTO VIAL TO DRAW UP MEDICATION, THE NEEDLE SEPARATED FROM THE HUB AND STUCK IN THE RUBBER STOPPER OF THE MEDICATION VIAL.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389147 ↗
• MalfunctionMar 16, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT 10 UNITS OF THE CUSTOMERS BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WERE CRACKED AND LEAK. IT IS UNSPECIFIED WHEN THE EVENT OCCURRED. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7346284 ↗

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-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-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-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-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-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-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-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-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