BD Luer-Lok 309577Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30382903095774), received between Apr 30, 2019 and Oct 10, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 21X1-1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309577. BATCH#: 5204814. VERBATIM: RCC RECEIVED A COMPLAINT VIA CALL. EMAIL(S) ATTACHED. CUSTOMER STATES THAT THE 3ML X 21G 1 1/2 SYRINGE NEEDLE COMBO CONTAINS A CLEAR STICKY LOOKING LIQUID WITH IN THE SYRINGE BARREL. CALLER STATES THAT THE WHOLE BOX DOES NOT LOOK THE SAME. CALLER STATES ONLY A FEW OF THE SYRINGES HAVE CONTIEND THE CLEAR SUBSTANCE. PRODUCT CODE 309577, LOT#5204814.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23272172 ↗
• MalfunctionApr 9, 2025Leak/Splash; Leak/Splash

  MATERIAL#: 309577. BATCH#: 4303844. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 21X1-1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MEDS SQUIRTING OUT THE SIDE. PRODUCT: 309577. LOT#: 4303844.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805042 ↗
• InjuryJun 17, 2024Defective Component; Defective Component

  MATERIAL# 309577 BATCH# 2318360 IT WAS REPORTED THAT THE BD LUER-LOK NEEDLE HUB HOLE/CRACKED/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE USING SYRINGE 309577 FOR INJECTION, HUB SNAPPED OFF, ALL MEDICATION LEAKED OUT AND CONSUMER WAS BLEEDING." CAT: 309577 LOT: 2318360 DATE OF EVENT: MAY 27TH. ADDITIONAL INFORMATION PROVIDED: 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. YES WHEN THE HUB BROKE OFF AND THE SYRINGE BARREL WENT INTO MY SKIN AND CAUSED A LACERATION WHICH REQUIRED SEVERAL STITCHES. THE EXPENSIVE (B)(6) MEDICATION SPILLED OUT AND COULD NOT BE ADMINISTERED THIS CAUSED INJURY AS A SCHEDULE 2 SUBSTANCE WAS DISCHARGED AND NOT ADMINISTERED. 2. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? THE SAMPLE IS AVAILABLE 3. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 19554584 ↗
• MalfunctionDec 13, 2023Break; Break

  NO ADDITIONAL INFORMATION

  Patient problems: Insufficient Information

  MAUDE report 18322083 ↗
• MalfunctionOct 29, 2023Break; Break

  IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE DOING A PROCEDURE, ONE OF THE SYRINGES SNAPPED IN HALF." PHYSICIAN CONTINUED PROCEDURE USING ANOTHER SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18027025 ↗
• MalfunctionJun 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GLUE LIKE LIQUID STRETCHES WITHIN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17205780 ↗
• MalfunctionMay 15, 2023Contamination; Contamination

  IT WAS REPORTED THAT GLUE-LIKE LIQUID WAS FOUND INSIDE THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS A LIQUID SUBSTANCE LIKE A GLUE INSIDE OF THE SYRINGE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934984 ↗
• MalfunctionJun 2, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 21X1-1/2 RB WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309577 BATCH NO. 2150297. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM SHELF CARTON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10112386 ↗
• MalfunctionApr 30, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT FIFTY SYRINGE 3ML LL W/NDL 21X1-1/2 RB EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309577 BATCH NO: 9008856. IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER HAS RECEIVED REPORTS THAT AT LEAST FIFTY SYRINGES WERE FOUND TO HAVE DEFECTIVE/BLURRED SCALE MARKINGS. NO PTS WERE IMPACTED AND AFFECTED SAMPLES ARE AVAILABLE. ONLY SEEING ISSUES WITH THIS LOT. DATE OF OCCURRENCE IS NOW KNOWN PER CUSTOMER ON PHONE CALL.

  Patient problems: No Information

  MAUDE report 8567127 ↗

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-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-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-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-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-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-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-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