BD Luer-Lok 305062Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382903050628), received between Apr 4, 2018 and Jan 7, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Material Perforation

  IT WAS REPORTED THAT THE BD SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2 NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305062 BATCH #5297089. RCC RECEIVED A COMPLAINT VIA EMAIL. I WANT TO REPORT AN INCIDENT THAT HAPPENED YESTERDAY (B)(6) 2025 AT (B)(6). AN EMPLOYEE WAS STOCKING SYRINGES AND ONE OF THE NEEDLES POCKED HIS MIDDLE FINGER IN THE OPEN PALM SIDE OF HIS LEFT HAND. IT WAS AN UNUSED UNOPENED NEEDLE (SEE ATTACHED PICTURES) WITH A DEFECTIVE CAP ON THE NEEDLE. THE SYRINGE IS SEQUESTERED. SUPPLIER: (B)(4).

  Patient problems: Needle Stick/Puncture

  MAUDE report 23998544 ↗
• MalfunctionJan 9, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 305060. BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC GOING INTO THE VIALS OF DRUGS WHEN USING BLUNT FILL NEEDLES. SUPPLY CHAIN AND PHARMACY HAD TO PULL ALL 305060, 305062, AND 305180 OFF THE SHELVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111914 ↗
• MalfunctionJan 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 305062 , BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PLASTIC GOING INTO THE VIALS OF DRUGS WHEN USING BLUNT FILL NEEDLES. SUPPLY CHAIN AND PHARMACY HAD TO PULL ALL 305060, 305062, AND 305180 OFF THE SHELVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21104867 ↗
• MalfunctionOct 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIALS: 305062, BATCH#: 4157854. IT WAS REPORTED THAT THE BD SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2 HAD CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE #: (B)(4). HOSPITAL COMPLAINT REFERENCE #: (B)(4). CUSTOMER (HOSPITAL) NAME: (B)(6). CUSTOMER ADDRESS: XXX XXXX XXX PH:XXX-XXX-XXXX XXXXX, XXXX, XX, XXXXX, XXXX. CONTACT NAME: XXXX XXX. PHONE: XXX-XXX-XXXX XXX. E-MAIL: [email protected]. CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD305062. DESCRIPTION OF PRODUCT: NEEDLE BLUNT FILL 18GX1.5IN W/LL 5ML SYRNG 100EA/BX 4BX/CA. LOT OR S/N: 4157854. COMPLAINT CATEGORY: FOREIGN MATTER / MATERIAL / DIRTY. REPORTABLE: NO. INCIDENT DATE: 12 SEP 2024. HOSPITAL COMPLAINT REFERENCE #: (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): RUBBER STOPPER BIT GOING INTO THE VIAL AFTER BLUNT NEEDLE IS USED TO DRAW UP MEDICATION. PLEASE SEE THE PICTURE WITH THE RUBBER FLOATING IN THE MEDICATION FROM THE 5ML SYRINGE GOING INTO THE VIAL AND POKING THE RUBBER INTO THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423679 ↗
• MalfunctionSep 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321073 ↗
• MalfunctionJan 23, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY DUE TO CORING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE END USER HAS NOTICED THAT THESE ARE CORING THE VIALS. THEY HAVE FOUND PIECES OF THE RUBBER MEDICATION VIALS IN THE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230148 ↗
• MalfunctionApr 22, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT PRIOR TO USING A BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE 18 G X 1 1/2 IN., STERILE SINGLE USE, NOT FOR SKIN INJECTION, 5 ML, THE SCALE MARKINGS WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE DIDN T HAVE ML MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190691 ↗
• MalfunctionApr 21, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE LACKED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "CX HAS A DEFECTIVE SYRINGE (PART# 305062) THAT SHE NEEDS TO RETURN TO BD FOR REVIEW. THE SYRINGE DIDN T HAVE ML MARKINGS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167089 ↗
• MalfunctionNov 13, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2 STOPPER WAS DAMAGED AND ANOTHER SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305062 BATCH NO. 0199226, UNKNOWN. IT WAS REPORTED THAT STOPPER LOOKS MELTED INSIDE ONE SYRINGE AND ANOTHER SYRINGE HAD MEDICATION THAT LEAKED BEHIND STOPPER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837764 ↗
• MalfunctionFeb 12, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 5 SYRINGES BLUNT FILL 5ML LL W/NDL 18X1-1/2 HAD FOREIGN CONTAMINATES FOUND IN THEIR SEALED PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE ARE CONTAMINATED ON THE INSIDE OF THE PACKAGING AND THE PACKAGING IS STILL SEALED. ALL WERE IN THE SUPPLY BIN LOCATED IN THE SUPPLY ROOM WHICH IS MANAGED BY MATERIALS MANAGEMENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700069 ↗
• MalfunctionSep 9, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 305062, BATCH NO. 8281966. IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP THE TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND IN OUR INVENTORY A BD 5ML SYRINGE LUER-LOCK TIP WITH BLUNT FILL NEEDLE 18G X 1 ½ WITH A DAMAGED PLUNGER TIP. CUSTOMER CALLED IN TO REPORT AN ISSUE WITH BD 5 ML SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8975049 ↗
• MalfunctionAug 3, 2018Material Discolored; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD¿ LUER-LOK¿ BLUNT FILL NEEDLE HAD AN OILY SUBSTANCE ON THE PLUNGER. THIS WAS DISCOVERED WHEN THE MEDICATION TURNED BROWN AFTER BEING DRAWN INTO THE SYRINGE. THE MEDICATION WAS PROPOFOL , WHICH IS WHITE IN COLOR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7747986 ↗
• MalfunctionApr 12, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MEASURE MARKINGS ON A BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP WERE ¿INCOMPLETE¿, AND MISSING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426003 ↗
• MalfunctionApr 4, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT SCALE MARKINGS ON A BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP WERE FOUND FADED MAKING THEM ILLEGIBLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7397006 ↗

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-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-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