BD Luer-Lok 309582Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903095827), received between Feb 25, 2019 and Apr 18, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1-1/2 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309582, LOT: 3115497. IT WAS REPORTED BY CUSTOMER THAT NEEDLE SEPARATED FROM SYRINGE, REMAINING IN THE SKIN. RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM(S): 309582, LOT(S): 3115497. DATE INCIDENT OCCURRED: ON (B)(6) 2025 THIS MORNING BUT HAS HAPPENED BEFORE. WAS THE PATIENT IMPACTED? IF YES, DESCRIBE: WITHDREW NEEDLE AND NEEDLE SEPARATED FROM SYRINGE, REMAINING IN THE SKIN. CUSTOMER RESPONSE RECEIVED ON 11-APR-2025: 1) WHAT WAS THE IMPACT TO THE PATIENT? WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? R: THERE WAS NO INJURY. 2) PLEASE PROVIDE US THE BD ORDER NUMBER AND PO NUMBER TO PROCESS THE REPLACEMENT. R: I AM A CONSUMER THEREFORE I HAVE NOBD ORDER NUMBER OR PO NUMBER. 3) SAMPLE AVAILABLE IS MENTIONED AS YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? R: PLEASE SHIP RETURN LABEL TO ME: 4) CAN YOU PROVIDE THE EXACT QUANTITIES THAT HAVE BEEN AFFECTED? R: THERE WERE 3 SYRINGES INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864271 ↗
• MalfunctionJul 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE MIXING MENVEO VACCINE, PUSHING DILUENT INTO VIAL 2/2 (POWDER), SOME LEAKED AROUND HUB, ANOTHER DOSE PULLED TO ENSURE ADEQUATE DOSING. BD (BECTON DICKINSON) SYRINGE 0351034. PATIENT NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417926 ↗
• MalfunctionMay 6, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G THE NEEDLE PULLED OUT OF THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDS- BD PLASTIPAK 3ML SYRINGES 309582. TWICE THE NEEDLE POP OFF THE SYRINGE WHILE INSTILLING THE DILUENT INTO THE COVID VIAL, CAUSING THE DILUENT TO SQUIRT OUT ONTO THE COUNTER. TWICE WE HAVE HAD THE NEEDLES POP OFF THE SYRINGE WHILE INSTILLING THE DILUENT INTO THE COVID VIAL, CAUSING THE DILUENT TO SQUIRT OUT ONTO THE COUNTER. WE HAVE HAD TO WASTE TWO VIALS OF VACCINE BECAUSE WE DID NOT KNOW HOW MUCH DILUENT WAS INJECTED INTO THE COVID VIAL AND HOW MUCH SQUIRTED OUT WHEN THE NEEDLE POPPED OFF THE SYRINGE. ARE YOU ABLE TO PROVIDE THE DATE OF OCCURRENCE FOR EACH INCIDENT? I AM NOT- THOUGH IT HAPPENED TWICE IN 1 WEEK. IS SAMPLE AVAILABLE TO RETURN FOR INVESTIGATION? YES. WAS THE PATIENT INVOLVED IN THIS INCIDENT? IF YES, WHAT WAS THE PATIENT OUTCOME? NO. WERE YOU ABLE TO CORRECT THE ISSUE BY USING ANOTHER NEEDLE OR GIVING IT A LITTLE TWIST- WE TRIED THAT AFTER THE FIRST INCIDENT AND THAT DID NOT SOLVE THE PROBLEM. I AM NOT SURE WHICH LOT NUMBER THAT THE OCCURRENCE HAPPENED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883449 ↗
• MalfunctionMar 31, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G THERE WERE CONNECTION ISSUES AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: I MENTIONED TO HER THAT THE BD 3ML 25G 1 1/2 SYRINGE/NEEDLE THAT SOMETIMES CAME WITH THE PEDIATRIC ANCILLARY KIT ACTUALLY DID NOT HAVE THE NEEDLE PART FIRMLY AFFIXED TO THE SYRINGE. THE SALINE SOLUTION CAN LEAK OUT FROM THE SIDE OF THE SYRINGE WHERE THE NEEDLE AND THE SYRINGE MEET. I THOUGHT THAT WAS THE WAY IT COMES IN AND THAT WE JUST HAVE TO BE MORE CAREFUL TO MAKE SURE THE NEEDLE IS AFFIXED TO THE SYRINGE FIRMLY BEFORE USING IT. THE AFFECTED VACCINES WERE REPORTED AS WASTE AND WERE NEVER USED FOR IMMUNIZATION. NOBODY RECEIVED AN INCORRECT DOSE AS A RESULT. THE NURSE TOLD ME THIS IS ACTUALLY CONSIDERED A DEFECT AND I SHOULD REPORT IT. THE LOT NUMBERS THAT WE HAVE ARE 0351034, 0351032, AND 0351028. THE TOTAL QUANTITY IS ABOUT 50 AND THEY ARE ALREADY SET ASIDE IN A BAG AND MARKED "DO NOT USE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659531 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN NP WAS DRAWING UP SHRINGRIX VACCINE, THE SYRINGE/NEEDLE COMBO LEAKED SOME OUT. IT WAS DISCARDED AND WASTED APPROPRIATELY AND NO ADMINISTRATION TO THE PATIENT OF THAT VACCINE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522985 ↗
• MalfunctionMar 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE NEEDLE POPPED OFF THE BD PLASTIPAK 3ML SYRINGE WHILE INSTILLING THE DILUENT INTO THE COVID VIAL, CAUSING THE DILUENT TO SQUIRT OUT ONTO THE COUNTER. THIS OCCURRED TWICE.

  Patient problems: Insufficient Information

  MAUDE report 16501236 ↗
• MalfunctionMar 6, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT 1 BD LUER-LOK¿ SYRINGE WITH BD PLASTIPAK¿ NEEDLE EACH FROM LOTS 0351036 AND 0351028 HAD ISSUES WITH THE NEEDLE SEPARATING FROM THE HUB AND LEAKING OUT THE COVID VACCINE DILUENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWICE WE HAVE HAD THE NEEDLES POP OFF THE SYRINGE WHILE INSTILLING THE DILUENT INTO THE COVID VIAL, CAUSING THE DILUENT TO SQUIRT OUT ONTO THE COUNTER. WE HAVE HAD TO WASTE TWO VIALS OF VACCINE BECAUSE WE DID NOT KNOW HOW MUCH DILUENT WAS INJECTED INTO THE COVID VIAL AND HOW MUCH SQUIRTED OUT WHEN THE NEEDLE POPPED OFF THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483791 ↗
• MalfunctionFeb 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PLUNGER ROD WAS INCORRECTLY POSITIONED "AT THE TOP" OF THE SYRINGE 3ML LL W/NDL 25X1-1/2 RB BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED THE PLUNGERS WERE ALL RESTED AT THE TOP OF SYRINGE AND NEVER SAW THIS BEFORE." "CONSUMER JUST PURCHASED THIS BOX AND IS FINDING THE PLUNGER STOPPER TO NOT HAD A GAP TO THE TOP OF SYRINGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9662403 ↗
• MalfunctionSep 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 3 ML LL W/NDL 25 X 1 - 1/2 RB EXPERIENCED TIP/LUER OF SYRINGE CRACKED/DAMAGED/DEFORMED/BENT WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309582, BATCH NO: 7198922. FROM PHONE CALL: SPOKE WITH PHARMACIST WHO CONFIRMED PRODUCT INFORMATION. REPLACED PRODUCT TO CONSUMER. STATED, NEEDLE BENT CLOSER TO HUB AREA. QUANTITY OF SYRINGES AFFECTED, UNKNOWN. EXPIRATION DATE: 2022-06-30. INCIDENT DATE: (B)(6) 2019. VERBATIM FROM EMAIL: THE NEEDLE IS CROOKED AT THE HUB AT THE PLASTIC PORTION IT IS VISIBLY CROOKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8982594 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED THAT BD 3ML PRECISIONGLIDE¿ SAFETY-LOK¿ SYRINGE NEEDLE BROKE OFF IN CUSTOMERS LEG. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309582 BATCH NO. 3330168. IT WAS REPORTED THAT NEEDLES ARE BREAKING OFF INTO A CUSTOMERS LEG. RECEIVED A CALL ABOUT AN ISSUE WITH PRODUCT 309582. SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ 3 ML 25 GAUGE 1-1/2 INCH. DETACHABLE NEEDLE WITHOUT SAFETY. SHE SAID THE NEEDLES ARE BREAKING OFF IN HER LEG WHICH REQUIRES SURGERY TO REMOVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843490 ↗
• MalfunctionFeb 25, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE USE OF THE BD 3ML PRECISIONGLIDE¿ SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE LOOKS TO BE A THREAD AND BROWN DOT ON THE INSIDE OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8366981 ↗

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-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-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-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