BD Luer-Lok 309579Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30382903095798), received between Jan 31, 2018 and Mar 23, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIALS #: 309579 BATCH #: 1022131. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE ROUGHLY 13 SYRINGES WITHOUT ANY MARKINGS. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT THEY HAVE ROUGHLY 13 SYRINGES WITHOUT ANY MARKINGS. THE CUSTOMER DOES HAVE UNUSED SAMPLES THEY CAN RETURN FOR INVESTIGATION IF NEEDED. CUSTOMER WOULD LIKE REPLACEMENTS. PRODUCT NUMBER: 309579; LOT NUMBER: 1022131.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965400 ↗
• MalfunctionMay 1, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES WITH PRECISIONGLIDE¿ NEEDLE HAD CROSS-THREADED NEEDLES ATTACHED TO THE SYRINGES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "158 UNITS HAVE BLACK SUBSTANCE ON THE SYRINGE TUBE ALSO BLACK DOTS ON THE TUBES. PLEASE CONFIRM IF THE FOREIGN MATTER IS ON THE OUTSIDE OF THE SYRINGE BARREL OR IN THE PATH OF FLUID. FROM WHAT WE CAN TELL WITHOUT OPENING THE PACKAGES IT APPEARS TO BE ON THE OUTSIDE OF THE BARREL." VIA BD INVESTIGATION TEAM: "ONE HUNDRED FIFTY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION... TWO SYRINGES HAVE A CROSS-THREADED NEEDLE ATTACHED TO THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844163 ↗
• MalfunctionMay 1, 2023Crack; Crack

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE HUB WAS BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "158 UNITS HAVE BLACK SUBSTANCE ON THE SYRINGE TUBE ALSO BLACK DOTS ON THE TUBES...". PLEASE CONFIRM IF THE FOREIGN MATTER IS ON THE OUTSIDE OF THE SYRINGE BARREL OR IN THE PATH OF FLUID. FROM WHAT WE CAN TELL WITHOUT OPENING THE PACKAGES IT APPEARS TO BE ON THE OUTSIDE OF THE BARREL.". VIA BD INVESTIGATION TEAM: "ONE HUNDRED FIFTY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION... ONE SYRINGE HAS A BROKEN NEEDLE HUB.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844159 ↗
• MalfunctionMay 1, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE STOPPER ON THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE PLUNGER WAS LOOSE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "158 UNITS HAVE BLACK SUBSTANCE ON THE SYRINGE TUBE ALSO BLACK DOTS ON THE TUBES... ... PLEASE CONFIRM IF THE FOREIGN MATTER IS ON THE OUTSIDE OF THE SYRINGE BARREL OR IN THE PATH OF FLUID. FROM WHAT WE CAN TELL WITHOUT OPENING THE PACKAGES IT APPEARS TO BE ON THE OUTSIDE OF THE BARREL.". VIA BD INVESTIGATION TEAM: "ONE HUNDRED FIFTY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION... ONE SYRINGE HAS AN INSECURE STOPPER ON THE END OF THE PLUNGER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844044 ↗
• MalfunctionMay 1, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE HAD NO SCALE PRINT FROM THE ZERO LINE TO THE 1/2ML AREA. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "158 UNITS HAVE BLACK SUBSTANCE ON THE SYRINGE TUBE ALSO BLACK DOTS ON THE TUBES. PLEASE CONFIRM IF THE FOREIGN MATTER IS ON THE OUTSIDE OF THE SYRINGE BARREL OR IN THE PATH OF FLUID. FROM WHAT WE CAN TELL WITHOUT OPENING THE PACKAGES IT APPEARS TO BE ON THE OUTSIDE OF THE BARREL." VIA BD INVESTIGATION TEAM: "ONE HUNDRED FIFTY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION... ONE SYRINGE IS MISSING PRINT FROM THE ZERO LINE TO THE 1/2ML AREA OF THE BARREL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844043 ↗
• MalfunctionJan 3, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 26 OF THE BD LUER-LOK¿ 3ML W/NDL WERE MISSING THE PRINTED PRODUCT INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 26 SYRINGES HAVE BEEN IDENTIFIED, SO FAR, AS MISSING THE PRINTED PRODUCT INFORMATION ON THE BACKSIDE OF THE SYRINGE STERILE BARRIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090902 ↗
• MalfunctionDec 6, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 11 BD LUER-LOK¿ 3ML W/NDL EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 11 SYRINGES HAVE BEEN IDENTIFIED, SO FAR, AS MISSING THE PRINTED PRODUCT INFORMATION ON THE BACKSIDE OF THE SYRINGE STERILE BARRIER. ANY INJURIES AND/OR HARM?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928507 ↗
• MalfunctionMay 14, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES WITH 2 BD LUER-LOK¿ 3ML W/NDL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3ML BD LUER LOCK SYRINGES THAT HAD ISSUES WITH MARKINGS. ONE HAS NO MARKINGS AND THE OTHER HAS MARKINGS THAT ARE NOT LEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825703 ↗
• MalfunctionOct 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND INSIDE THE SYRINGE 3ML LL W/NDL 20X1-1/2 RB NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS RECEIVED THE FOLLOWING CUSTOMER COMPLAINT FOR A WHITE. FOREIGN MATERIAL FOUND INSIDE THE NEEDLE 309579, LOT 9175481."

  Patient problems: No Patient Involvement

  MAUDE report 10738070 ↗
• MalfunctionJun 25, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 4 SYRINGES 3ML LL W/NDL 20X1-1/2 RB HAD A CRACKED BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 4 SYRINGES WERE FOUND TO HAVE THE BARREL CRACKED. (B)(4) CAPTURES THE INCIDENT DATE ON (B)(6) 2020. (B)(4) CAPTURES THE INCIDENT DATE ON (B)(6) 2020. PER PIR: THE ADMINISTRATOR AT (B)(6) CENTER EMAILED ME STATING THEY HAVE OPENED FOUR SYRINGES THAT HAVE HAD CRACKED BARRELS. THE REF NUMBER: (B)(4), WHICH IS 3ML SYRINGES W/ 20G X 1 1/2 IN. NEEDLE. THE LOT NUMBER ON THEM IS 9175481. SHE SAID IT ISN'T A HUGE DEAL BUT WANTED TO LET US KNOW AND HOW ODD IT WAS. THE BOX AND PACKAGING THAT THEY CAME IN HAVE NOT SHOWED ANY SIGNS OF DAMAGE. HER STAFF DID SAVE HER ONE FOR REFERENCE."

  Patient problems: No Patient Involvement

  MAUDE report 10196821 ↗
• MalfunctionJun 24, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT 4 BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLES 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.:309579 BATCH NO.:9175481. THE ADMINISTRATOR AT THE USER FACILITY EMAILED ME STATING THEY HAVE OPENED FOUR SYRINGES THAT HAVE HAD CRACKED BARRELS. THE REF NUMBER 309579, WHICH IS 3ML SYRINGES W/ 20G X 1 1/2 IN. NEEDLE. THE LOT NUMBER ON THEM IS 9175481. SHE SAID IT ISN'T A HUGE DEAL BUT WANTED TO LET US KNOW AND HOW ODD IT WAS. THE BOX AND PACKAGING THAT THEY CAME IN HAVE NOT SHOWED ANY SIGNS OF DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 10188117 ↗
• MalfunctionApr 29, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 20X1-1/2 RB WAS MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SYRINGES ARE MISSING THE SCALE MARKINGS. "THE NURSES HAVE BEEN BRINGING BACK SOME SYRINGES SAYING THERE ARE NO MARKINGS ON THEM TO DRAW UP DOSES. ALL THE FAULTY SYRINGES HAVE THE SAME LOT NUMBER. I HAVE ATTACHED A PICTURE BELOW SO YOU CAN SEE THE LOT. PLEASE FOLLOW UP WITH MATERIALS MANAGEMENT.""

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10010621 ↗
• MalfunctionApr 21, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SYRINGES HAVE BEEN FOUND WITHOUT PRINTED GRADUATION MARKS."

  Patient problems: No Patient Involvement

  MAUDE report 9981377 ↗
• MalfunctionDec 23, 2019Volume Accuracy Problem; Volume Accuracy Problem

  MATERIAL NO. 309579, BATCH NO. 9114915. IT WAS REPORTED THAT BEFORE USE OF THE BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE THE SYRINGES MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED SOME WITHOUT GRADUATION MARKINGS ON THE SYRINGES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511416 ↗
• MalfunctionApr 24, 2019Break; Leak/Splash

  IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WAS RECEIVED DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309579 BATCH NO.: 8329717. IT WAS REPORTED THE PRODUCT WAS RECEIVED DAMAGED. VERBATIM: PRODUCT IS DAMAGED/LEAKING/OUTDATED. PLEASE LET US KNOW IF A CALL TAG WILL BE ISSUED OR IF YOU WOULD LIKE US TO DESTROY OR DONATE THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544383 ↗
• MalfunctionJan 31, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BD LUER-LOK¿ SYRINGE WAS FOUND WITH FOREIGN MATTER AS THE SYRINGE WAS FOUND WITH AN ¿UNKNOWN LIQUID¿. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230962 ↗

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-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-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-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