BD Luer-Lok 309571Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00382903095711), received between Jun 1, 2018 and Feb 12, 2026 — classified as 31 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Connection Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 23X1 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. RCC RECEIVED A COMPLAINT VIA EMAIL. I WOULD LIKE TO REPORT THAT SEVERAL ANOMALIES WERE FOUND IN THE 3CC SYRINGES FROM LOT: 5276052, EXPIRY DATE: 30 SEPTEMBER 2030. IT HAD BEEN NOTED THAT SOME 3CC SYRINGES FROM THE LOT: 5276052 DID NOT SCREW ON PROPERLY OR HAD CERTAIN ANOMALIES (NEEDLE WITHOUT BEVEL, BENT NEEDLE, ETC.). THESE FINDINGS WERE UNDER INVESTIGATION WHEN THIS EVENT OCCURRED. WE WOULD LIKE TO DISCUSS WITH YOU POSSIBLE RECENT CHANGES IN THE MANUFACTURING PROCESS FOR 3CC SYRINGES. ADDITIONAL INFORMATION WAS RECEIVED ON 02/09/2026: 1. COULD YOU PROVIDE US WITH THE EXACT DATE OF THE INCIDENT IN MM-DD-YYYY FORMAT? OUR FIRST CASES STARTED AT THE BEGINNING OF NOVEMBER, UNFORTUNATELY I DO NOT HAVE AN EXACT DATE; BUT MY TEAM FINDS SAMPLES THAT ARE NOT COMPLIANT WITHIN 2-3 DAYS. 2. DID THIS EVENT RESULT IN ANY DAMAGE, INJURY, COMPLICATION OR NEGATIVE CONSEQUENCES FOR THE PATIENT? NO, THE SYRINGES ARE THROWN AWAY, THEY WERE NOT SENT TO OUR CLIENTS WHEN ANOMALIES ARE DETECTED. 3. IS A PHYSICAL SAMPLE OF THE PRODUCT PRESENTING THE REPORTED PROBLEM AVAILABLE? IF YES, PLEASE PROVIDE US WITH THE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329695 ↗
• MalfunctionJul 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 23X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309571 BATCH#: 4215854 & 4205336 VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED CALLER STATES THEY HAVE PRODUCT CODE 309571, LOT# 4215854 AND 4205336. CALLER STATES THEY CAN SEE A CLEAR RESIDUE IN THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572438 ↗
• MalfunctionJul 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572434 ↗
• MalfunctionFeb 4, 2025Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309551 ↗
• MalfunctionJan 31, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619309 ↗
• MalfunctionSep 26, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT 3 CASES OF BD LUER-LOK¿ SYRINGES WITH ATTACHED NEEDLE HAD NO LOT/EXPIRATION DATES ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOVERED AN ADDITIONAL THREE CASES THAT DID NOT HAVE THE SECONDARY BARCODE ALONG WITH THE LOT/EXPIRATION DATE ON THE LABEL... 2. WAS ANY OF THE PRODUCT USED ON PATIENT? IF YES, WHAT WAS THE PATIENT OUTCOME. NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821692 ↗
• MalfunctionSep 21, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT 3 BD LUER-LOK¿ SYRINGES WITH ATTACHED NEEDLE HAD NO LOT/EXPIRATION DATE ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED AND DISCOVERED AN ADDITIONAL THREE CASES THAT DID NOT HAVE THE SECONDARY BARCODE ALONG WITH THE LOT/EXPIRATION DATE ON THE LABEL. "

  Patient problems: Insufficient Information

  MAUDE report 17795517 ↗
• MalfunctionAug 15, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT 3 BOXES OF BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE'S ARE MISSING LOT OR EXPIRATION DATES. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: DAMAGE (PACKAGING ISSUE): PACKAGE DOES NOT CONTAIN LOT # OR EXPIRATION DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552457 ↗
• MalfunctionJul 17, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO USE WITH BD 3ML LL NEEDLE 23G 1IN REGULAR BEVEL TW THE SHIPPER LABEL WAS MISSING A BARCODE AND THE LOT NUMBER AND EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER DISCOVERED A POTENTIAL PRODUCT QUALITY ISSUE WITH SYR+NDL LL BD 3ML 23GX1 100 (DEV 04013). CUSTOMER DISCOVERED SOME OF THE BOXES ONLY HAD ONE BAR CODE LOCATED ON THE BOX AND OTHERS HAD TWO. PICTURE RECEIVED ALSO SHOWS THAT LOT AND EXP DATE ARE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339256 ↗
• MalfunctionJun 1, 2023Contamination; Contamination

  IT WAS REPORTED THAT 120 BD LUER-LOK¿ SYRINGES WITH ATTACHED NEEDLE HAD WHITE FOREIGN MATTER ON THEIR NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED TO HAVE SOMETHING WHITE ON THE NEEDLE ITSELF, RENDERING IT USELESS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17044008 ↗
• MalfunctionMay 12, 2023Contamination; Contamination

  IT WAS REPORTED THAT 4 BD LUER-LOK¿ SYRINGES WITH ATTACHED NEEDLE HAD WHITE FOREIGN MATTER ON THE NEEDLES WHILE STILL IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: THEY HAVE FOUND 3-4 NEEDLES THAT HAVE SOMETHING "WHITE" ON THE NEEDLE ITSELF, RENDERING IT USELESS... WHERE WAS THE FM LOCATED? IN THE FLUID PATH? INSIDE OR OUTSIDE PACKAGING? INSIDE THE PACKAGE. WHAT DID THE FM LOOK LIKE? (COLOR / SIZE, LIQUID LIKE OR POWDER LIKE) WHITE, LOOKS LIKE A PAINT SUBSTANCE. WAS THERE ANY PATIENT INVOLVEMENT? IF YES, WHAT IS THE PATIENT OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? NO ¿ THE SUBSTANCE WAS NOTICED PRIOR TO USING FOR MEDICATION DRAW OR ANY DIRECT PATIENT CARE. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NEW NEEDLE WAS PULLED AND USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923329 ↗
• MalfunctionJul 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I OPENED A NEW SYRINGE NEEDLE AND NOTICED A HAIR OR METAL SLIVER ON THE END OF THE NEEDLE (IT WAS HARD TO TELL) I PUT THE CAP ON, THEN REMOVED THE CAP, PULL THE PLUNGER BACK TO GET THE LIQUID OUT OF THE NEEDLE, PUT THE CAP BACK ON, REPLACED THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207230 ↗
• MalfunctionJun 2, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 23X1 RB WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED: MISSING EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925736 ↗
• MalfunctionNov 21, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BOX OF SYRINGES 3ML LL W/NDL 23X1 RB HAD NO EXPIRATION DATE ON THE LABEL. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 6 BOXES OF SYRINGES (100 COUNT PER BOX) THAT DO NOT HAVE AN EXPIRATION DATE ON THE BOX AND PACKAGING."

  Patient problems: No Patient Involvement

  MAUDE report 10880909 ↗
• MalfunctionSep 24, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 3 BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED MISSING LABEL INFORMATION AND INCORRECT LABEL INFORMATION. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(6) BATCH NO: 5244859. PHARMACY AND DOES NOT HAVE ANY RETAIL. PHARMACY TECH NOTICED THE BOTTOM HAS AN EXPIRATION DATE THAT DOES NOT MATCH THE EXPIRATION DATE GIVEN TO HER BY A BD REP WHEN SHE CALLED THE CUSTOMER SERVICE LINE. MISSING THE "EXP " ON THE BOTTOM OF THE BOX BUT THERE IS A DATE BUT IS ASSUMING THIS IS THE EXPIRATION DATE. ISSUE IS WITH 3 BOXES OF 100 PER BOX.

  Patient problems: No Patient Involvement

  MAUDE report 10578296 ↗
• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 23X1 RB NEEDLE BROKE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309571, BATCH NO. UNKNOWN IT WAS REPORTED THAT THE NEEDLE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254898 ↗
• MalfunctionApr 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SHOT OF B12 MEDICATION LEAKED FROM THE THREADED CONNECTION POINT AT THE TIP OF THE BD LUER-LOK¿ TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1 SYRINGE FOUND TO BE FAULTY TODAY BECAUSE ALL OF THE MEDICATION SPILLED OUT AT THE THREADED CONNECTION POINT AT THE TIP OF THE SYRINGE. DIRECT CONSUMER HOME USER TAKES 1 B12 SHOT EVERY MONTH, RECEIVES FORM PHARMACY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9981167 ↗
• MalfunctionJan 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL NO: 309571 BATCH NO: 9177496. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 3ML LL W/NDL 23X1 RB A PIECES OF CARDBOARD WAS FOUND IN THE CAP OF THE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION PER ATTACHED EMAIL STATES: PIECE OF CARDBOARD PRESENT IN CAP OF SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554239 ↗
• MalfunctionDec 31, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE THE SYRINGE LEAKED WITH A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE HAD A LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9535382 ↗
• MalfunctionDec 11, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 23X1 RB EXPERIENCED A MOLDING DEFECT -SHARP PROTRUSIONS WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309571 BATCH NO: 9189738. PER COMPLAINT DESCRIPTION: WE RECEIVED A VOICEMAIL STATING THAT PRODUCT 309571, HAD EXTRA PIECE OF PLASTIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9451650 ↗
• MalfunctionMay 24, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A CRACK IN SYRINGE A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309571 BATCH NO.: 9056847. (2 OF 2) IT WAS REPORTED ONE SYRINGE CRACKED AND LEAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8640979 ↗
• MalfunctionMay 8, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 23X1 RB EXPERIENCED CRACKING AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309571 BATCH NO.: 9056847. IT WAS REPORTED ONE SYRINGE CRACKED AND LEAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8593414 ↗
• MalfunctionMar 12, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE THE SYRINGES CRACKED CAUSING THE MEDICINE TO SPILL OUT ONTO THE FLOOR. PER MANUFACTURER NOTICE: OFFICE MANAGER SAID THEY USE THESE SYRINGES ALL THE TIME AND THIS MOST RECENT TIME ON THREE DIFFERENT PATIENTS THEY WERE PERFORMING B12 SHOTS WHEN THE SYRINGES WOULD CRACK RESULTING IN THE MEDICINE SPILLING OUT ONTO THE FLOOR AND NOT BEING INJECTED INTO PATIENT. ALL PATIENTS ARE FINE AND NO MEDICAL ATTENTION REQUIRED. THIS HAPPENED WITHIN THE LAST FEW WEEKS. ALL FROM THE SAME LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413768 ↗
• MalfunctionMar 8, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 23X1 RB EXPERIENCED A CRACKED BARREL AND LEAKAGE. THE ORIGINAL REPORT STATED, "OFFICE MANAGER SAID THEY USE THESE SYRINGES ALL THE TIME AND THIS MOST RECENT TIME ON THREE DIFFERENT PATIENTS THEY WERE PERFORMING B12 SHOTS WHEN THE SYRINGES WOULD CRACK RESULTING IN THE MEDICINE SPILLING OUT ONTO THE FLOOR AND NOT BEING INJECTED INTO PATIENT. ALL PATIENTS ARE FINE AND NO MEDICAL ATTENTION REQUIRED. THIS HAPPENED WITHIN THE LAST FEW WEEKS. ALL FROM THE SAME LOT NUMBER.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8403771 ↗
• MalfunctionMar 7, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT BD¿ SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP CRACKED CAUSING THE MEDICINE TO SPILL OUT ONTO THE FLOOR. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO.: 309571 BATCH NO.: 8334805. IT WAS REPORTED THE SYRINGES CRACKED CAUSING THE MEDICINE TO SPILL OUT ONTO THE FLOOR. PER MANUFACTURER NOTICE: OFFICE MANAGER SAID THEY USE THESE SYRINGES ALL THE TIME AND THIS MOST RECENT TIME ON THREE DIFFERENT PATIENTS THEY WERE PERFORMING B12 SHOTS WHEN THE SYRINGES WOULD CRACK RESULTING IN THE MEDICINE SPILLING OUT ONTO THE FLOOR AND NOT BEING INJECTED INTO PATIENT. ALL PATIENTS ARE FINE AND NO MEDICAL ATTENTION REQUIRED. THIS HAPPENED WITHIN THE LAST FEW WEEKS. ALL FROM THE SAME LOT NUMBER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401142 ↗

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-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-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-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-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