BD Luer-Lok 309574Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30382903095743), received between Jan 28, 2019 and Dec 3, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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.

• MalfunctionDec 3, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD A BROKEN PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER BENT & BROKE WHILE DR. WAS INJECTING SOMEONE. IT APPEARS THAT FULL BOX OF SYRINGES SEEM FLIMSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912112 ↗
• MalfunctionAug 4, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THERE IS A HOLE IN THE NEEDLE HUB OF A BD PLASTIPAK¿ LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A HOLE IN THE NEEDLE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168360 ↗
• MalfunctionJul 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT 2 BD LUER-LOK¿ TIP SYRINGES WITH THE BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED NEEDLES THAT WERE PULLED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BEEN GIVING MY HUSBAND HIS TESTOSTERONE INJECTIONS FOR YEARS. WE RECENTLY PURCHASED ANOTHER SUPPLY OF SYRINGES WITH A LUER-LOK NEEDLE. THIS BATCH DID NOT HAVE THE NEEDLE SCREWED INTO THE SYRINGE. AS I WAS TRYING TO FILL THE SYRINGE THE NEEDLE CAME OFF AND WE LOST THE MEDICATION. I TRIED AGAIN WITH AN UNOPENED PACKAGE AND THE SAME THING HAPPENED AGAIN. THE NEEDLE APPEARED TO LOOK SECURE, BUT IT WAS NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100274 ↗
• MalfunctionMay 6, 2022Crack; Crack

  IT WAS REPORTED THAT THE BARREL OF THE BD LUER-LOK¿ TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE SPLIT WHILE INJECTING MEDICATION INTO THE PATIENT. THIS OCCURRED TWICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2ML SYRINGE (PRELOADED 22 GA 1.5-INCH NEEDLE. WHEN USING SYRINGE TO INJECT MEDICATION INTO PATIENT THE SYRINGE BARREL SPLITS LONGITUNDINALLY. THIS HAS HAPPENED TWICE. PRODUCT # 309547; LOT 2033017, EXPIRATION 1/31/2027".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309450 ↗
• MalfunctionDec 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 22X1-1/2 RB CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TIP OF THE NEEDLE IS CONTAMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960052 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1-1/2 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED LEAKING. VERBATIM: CUSTOMER STATED THAT SHE HAS BEEN HAVING ISSUES WITH THE NEEDLES SINCE 6/28/2021. SHE STATED AT LEAST 2 OR 3 A WEEK ARE DULL OR LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423820 ↗
• MalfunctionAug 5, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1-1/2 RB WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE USER FACILITY THAT THERE WAS A PUNCTURE HOLE IN THE SYRINGE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284545 ↗
• MalfunctionMay 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1-1/2 RB WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309574 BATCH NO: 0364901. IT WAS REPORTED THE COVER AND THE NIPPLE IN THE LUER-LOCK ARE WARPED. NEEDLE ALSO BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868125 ↗
• MalfunctionMay 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1-1/2 RB NEEDLE WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309574 BATCH NO: 0339480. IT WAS REPORTED THE NEEDLE IS ATTACHED TO THE SYRINGE, BUT NOT TIGHTLY. VERBATIM: WHEN THE CLINICIAN OPENS THE PRODUCT THE NEEDLE IS ATTACHED TO THE SYRINGE, BUT NOT TIGHTLY. AS A RESULT, THERE IS SLIGHT LEAKAGE DURING THE RECONSTITUTION OF THE PFIZER COVID VACCINE. AFTER EXPERIENCING THIS ISSUE MULTIPLE TIMES, THE CLINICIAN MADE THE COMMENT THAT, WITH THIS BD PRODUCT, HE NOW MANUALLY TIGHTENS THE NEEDLE ON EACH UNIT PRIOR TO USE. LOSS OF DILUENT/DRUG. EXTRA STEP NOW REQUIRED TO ASSURE NEEDLE IS TIGHTLY ATTACHED TO SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855925 ↗
• MalfunctionFeb 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT COVID VACCINATION MEDICINE LEAKED FROM THE SYRINGE 3ML LL W/NDL 22X1-1/2 RB AND NEEDLE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE LUER-LOK CONNECTION BETWEEN THE PRE-PACKAGED NEEDLE AND SYRINGE WAS NOT SECURELY CONNECTED (TIGHTLY SCREWED TOGETHER), RESULTING IN LEAKAGE OF DILUENT FROM THE LEUR-LOK CONNECTION. THIS BROKE ASEPTIC TECHNIQUE/FIELD AND RESULTED IN WASTE OF FULL VIAL (WHICH IS A LOSS OF 5 COVID VACCINES). NO HARM TO PATIENT OR EMPLOYEE; FULL VIAL OF PFIZER BIONTECH COVID-19 VACCINE VIAL WAS WASTED AS A RESULT; YES, I RETAINED THE BD PLASTIPAK 3 ML SYRINGE/NEEDLE; I DID NOT SEE PHYSICAL DEFECT ON INSPECTION, THE NEEDLE AND SYRINGE WERE NOT TIGHTLY SCREWED TOGETHER".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11263879 ↗
• MalfunctionOct 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 12 SYRINGES 3ML LL W/NDL 22X1-1/2 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT MEDICATION LEAKED NEAR THE PLUNGER ROD AREA. EVENT DESCRIPTION PER SNOW VERBATIM STATES: ECONSUMER REPORTED, WHEN SHE WAS DRAWING UP MEDICATION, IT LEAKED NEAR THE PLUNGER ROD AREA 12 SYRINGES AFFECTED. LOT: 0121703, (CONSUMER HAS POOR EYESIGHT). CATALOG: 309574. DATE OF EVENT: UNKNOWN. SAMPLES: YES. MEDICATION: B-12 CL".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10752231 ↗
• MalfunctionJun 4, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE 2 "GLOBS OF WHITE FOREIGN MATTER FOUND ON NEEDLE PRIOR TO INJECTION WITH A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISION GLIDE¿ NEEDLE." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER FOUND "2 GLOBS OF WHITE STUFF ABOUT HALFWAY UP THE SHAFT OF THE NEEDLE" PRIOR TO INJECTION INTO VIAL. HE IS A HOME USER, HIS WIFE USUALLY GIVES INJECTIONS."

  Patient problems: No Patient Involvement

  MAUDE report 10119386 ↗
• MalfunctionJan 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL W/NDL 22X1-1/2 RB HAS BEEN FOUND EXPERIENCING FOUR OCCURRENCES OF CONTAINING MIXED PRODUCT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLES ARE DULL RESULTING IN PAIN TO THE USER UPON INJECTION. ADDITIONALLY, IT WAS REPORTED THE NEEDLE SIZE IS DIFFERENT. VERBATIM: CONSUMER REPORTED NEEDLE IS SO DULL, BARELY GET IT THROUGH THE BOTTLE, HE HAS TO USE EXCESSIVE FORCE IN INSERT THE NEEDLE INTO THE VIAL AT THE GREY SEAL OF THE VIAL. HE USES THE TESTOSTERONE. THE SAME NEEDLES WHEN HE USED IT ON THE SKIN HE WAS BLEEDING. HE HAD PAIN. HE DID NOT SEEK MEDICAL ATTENTION. HE USED THE ALCOHOL SWAB TO WIPE AND USED THE BAND AID ON IT. HE HAS REFILLED THE NEW PRESCRIPTION, IT IS THE SAME LOT# HAVE NOT USED THE NEW BOX YET. CONSUMER REPORTED THESE NEEDLE LOOK DIFFERENT SHAPE DIFFERENT , SIZE IS DIFFERENT, THEY ARE DULL. HE IS GETTING THE SAME NEEDLES LIKE IN THE PAST, NO CHANGES ON THE PRESCRIPTION. THESE NEEDLE ARE NOT THE SAME. HE USES THE BD 9574SYR/ NDL 3ML 22GX, HE HAS USED THE SAME TYPE OF NEEDLES BEFORE. THESE NEEDLES FROM THE BOX ARE DULL. SAMPLE DISCARDED. CONSUMER USES THE NEW NEEDLE EACH TIM

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 9555032 ↗
• MalfunctionNov 21, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL 22X1-1/2 RB EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309574; BATCH NO.: 9008859. VERBATIM: CUSTOMER NOTICED A WHITE, WAXY LIQUID WHEN USING THE SYRINGE AND WAS WONDERING IF THIS WAS NORMAL. CUSTOMER WANTS TO KNOW IF IT IS OK TO USE THE SYRINGES OR IF THEY NEED TO BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355484 ↗
• MalfunctionJul 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL NO: 309574, BATCH NO: 8267611. IT WAS REPORTED THAT DURING USE OF THE BD¿ LUER-LOK SYRINGE THE SYRINGE NEEDLE HURT DURING INJECTION AND UPON INSPECTION OF THE NEEDLE THE CONSUMER NOTICED A WHITE HARD SUBSTANCE ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REPORTED ON CONSUMER'S BEHALF THAT THE SYRINGE NEEDLE HURT DURING INJECTION AND UPON INSPECTION OF THE NEEDLE THE CONSUMER NOTICED A WHITE HARD SUBSTANCE ON THE NEEDLE. CONSUMER CALLED HER PHYSICIAN TO INQUIRE ABOUT THE NEEDLE BUT SHE DID NOT SEEK MEDICAL ATTENTION. LOT # 8267611, PRODUCT # 309574, EXP 03-09-2023. OCCURRENCE DATE IS UNKNOWN, PHARMACIST WILL ASK CONSUMER TO CONTACT US DIRECTLY TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8768718 ↗
• MalfunctionFeb 13, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD¿ LUER-LOK SYRINGE OIL DROPLETS ARE SEEN ON THE PISTON OF ALL SYRINGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336377 ↗
• MalfunctionJan 28, 2019Leak/Splash; Defective Component

  IT WAS REPORTED THAT FIVE STOPPERS OF FIVE BD¿ LUER-LOK SYRINGES WERE DEFECTIVE AND IMPROPERLY SUITING INTO THEIR PLACE, PROBABLY CAUSING LEAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283448 ↗

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-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-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-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-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-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-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