BD Luer-Lok 309643Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903096435), received between Dec 28, 2018 and Mar 17, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Product Quality Problem; Material Perforation

  IT WAS REPORTED THAT BD SYRINGE 10ML LL W/NDL 21X1-1/2 RB NEEDLE WENT THROUGH SHIELD. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DATE: 23.02.2026 COMPLAINT NUMBER: (B)(4). ITEM NUMBER: 308-309643. LOT # / SERIAL #: (B)(6). SAMPLE AVAILABLE: YES. ITEM DESCRIPTION: 10ML LL STER SYRINGE W/ 21GX1.5" NDL REG. INCIDENT DESCRIPTION: AS PER CLIENT, THE NEEDLE HAS GONE THROUGH THE PROTECTIVE CAP AND THE PLASTIC ON THE PACKAGE - COULD HAVE RESULTED IN SOMEONE GETTING A NEEDLE STICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618181 ↗
• MalfunctionAug 21, 2024Packaging Problem; Packaging Problem

  MATERIAL #: 309643, BATCH#: 3124837. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21X1-1/2 RB WAS MIXED PRODUCTS/LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. FOUND NON-STERILE PRODUCT IN STERILE PACKAGING WHILE STOCKING SYRINGES IN PHARMACY. ITEM -309643, LOT-3124837.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016458 ↗
• MalfunctionJun 7, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT UNSPECIFICED NUMBER OF BD LUER-LOK¿ SYRINGE WAS DEFECTIVE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIP OF THE NEEDLE (THE PART THAT SCREWS INTO THE SYRINGE) IS PIERCED AND LIQUIDS LEAK OUT DURING PREPARATION. ACCORDING TO THE STAFF, THIS TYPE OF INCIDENT HAS OCCURRED A FEW TIMES IN RECENT WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081631 ↗
• MalfunctionJan 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE THE NEEDLE PIERCED THE SHIELD. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILS OF COMPLAINT (REPORTED ISSUE): FROM CLIENT'S EMAIL: "UPON OPENING THE SYRINGE THE NEEDLE WAS PROTRUDING THROUGH THE END OF THE CAP, WHICH WAS TOO SHORT TO COVER IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147994 ↗
• MalfunctionNov 26, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE SYRINGE 10ML LL W/NDL 21X1-1/2 RB EXPERIENCED DISCOLORED/STAINED PRIMARY PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED 400 EACH OF ITEM 309643/106005L, LOT NUMBER 0238480, EXPIRING 07-31-2025 ON PO 20809.

  Patient problems: No Patient Involvement

  MAUDE report 10908873 ↗
• MalfunctionAug 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 10ML LL W/NDL 21X1-1/2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HEALTH PROFESSIONAL REPORTED UPON OPENING TWO PACKAGES THEY FOUND FUZZ ON THE NEEDLE AND ONE OF THEM HAD MOISTURE INSIDE OF THE BARREL TOWARDS THE END." (B)(4) OCCURRENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8894572 ↗
• MalfunctionFeb 13, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER ON THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336270 ↗
• InjuryJan 2, 2019Break; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WAS "BROKEN LONGITUDINALLY" DURING USE AND "MADE A BLOOD SPLATTER WHERE THE WHOLE ROOM WAS SPLASHED WITH BLOOD AND THE DOCTOR'S EYES WERE ALSO EXPOSED". HOWEVER, THERE WAS NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 8210295 ↗
• MalfunctionDec 28, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ THERE WAS AN ISSUE WITH FOREIGN MATTER ON THE TOP OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203788 ↗

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-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-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-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