BD Luer-Lok 305060Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00382903050604), received between Nov 10, 2017 and May 5, 2026 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (23 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 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL BARREL/FLANGED WAS DAMAGED. VERBATIM: RN DREW AND ADMINISTERED FENTANYL TO A PATIENT, AND UPON DRAWING UP LT TO FLUSH THE LINE RN OBSERVED A LEAK COMING FROM THE SYRINGE AND FOUND A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084387 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FIL HAD A NEEDLE DEFECT. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC XXX AND XXX ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO, ITEM: 305060, QUANTITY AFFECTED: 1 CS, SERIAL/LOT NUMBER: (B)(6), PO: (B)(4), ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: HEY (B)(6), CAN YOU REPORT THIS ITEM REF - 305060 3 ML SYRINGE LL BLUNT TIP 18GA 1 LOT#: 5317756, NEEDLE BASE BROKE DURING MED DRAW. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916208 ↗
• MalfunctionMar 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL CONTAINED FOREIGN MATTER. VERBATIM: ¿THERE WAS AN ISSUE WITH THE 3 ML SYRINGE OVER THE WEEKEND IN PICU. A NURSE OPENED A PREVIOUSLY UNOPENED 3 ML SYRINGE (ITEM 305060) AND NOTICED A CLEAR, STRINGY LIQUID (ABOUT 0.25 ML) INSIDE. THE AFFECTED LOT NUMBER WAS 5345829. THE FLOOR DISCARDED THE SYRINGE, SO WE NO LONGER HAVE THE CONTAMINATED ITEM.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640148 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL NEEDLE BROKE. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AN MD WAS PULLING UP A MEDICATION FROM A VIAL USING A BLUNT TIP NEEDLE AND THE NEEDLE SNAPPED IN HALF CREATING A WPS RISK. BLUNT TIP NEEDLES ARE USED TO PULL UP MEDICATIONS, BUT ARE NOT USED TO INJECT INTO PATIENTS. THIS NEEDLE TYPE IS REGULARLY USED IN DSA DERMATOLOGY TO PULL UP MEDICATIONS INTO A SYRINGE. I HAVE NOT BEEN AWARE OF ANY SIMILAR ISSUES IN THE PAST WITH THE BLUNT TIP NEEDLES. THE MD WAS PROPERLY USING THE SYRINGE/BLUNT TIP NEEDLE TO PULL UP A MEDICATION FROM A VIAL. THE MD STATED THEY DID NOT USE ANY FORCE OR ENCOUNTER ANY ISSUE THAT PUT OUTSIDE OF NORMAL STRAIN ON THE DEVICE FOR ITS USE. THE NEEDLE SNAPPED CLOSE TO THE HUB, BUT THE BREAK WAS IN THE METAL NEEDLE ITSELF. ESCALATE TO LOCAL PRODUCT COUNCIL REPRESENTATIVE - DONE. NOTIFY PLS MATERIALS MANAGER OF THE PRODUCT ISSUE - DONE. RRF TO BE FILLED OUT DUE TO SAFETY RISK WITH A METAL (BLUNT) NEEDLE SNAPPING WITH NORMAL USE ¿ COMPLETING TODAY. WPS RISK INFORMATION WAS SHARED WITH DSA DERMATOLOGY STAFF/MANAGERS - DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618183 ↗
• MalfunctionFeb 3, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL PACKAGE WAS DAMAGED / DEFECTIVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE STERILE PACKAGING WAS NOT SEALED WHEN THEY WERE TAKEN OUT OF THE BOX. PRODUCT#: 305060 LOT#: 5273064

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249028 ↗
• MalfunctionNov 12, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538778 ↗
• MalfunctionOct 20, 2025Break; Defective Component; Break; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336862 ↗
• MalfunctionOct 20, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336855 ↗
• MalfunctionJul 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  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: MATERIAL # 305060 BATCH # 5023149 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WENT TO MIX AMPICILLIN; UPON DRAWING UP STERILE WATER TO MIX IN THE AMPICILLIN, A SMALL CIRCULAR PARTICLE WAS NOTED TO BE FLOATING THE FLUID FILLED SYRINGE. SITE BELIEVES THE DEBRIS CAME FROM THE VIAL OF WATER PRODUCT#: 305060 LOT#: 5023149.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510966 ↗
• MalfunctionFeb 25, 2025Device 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 21464971 ↗
• MalfunctionFeb 20, 2025Device 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 21421157 ↗
• MalfunctionFeb 13, 2025Defective Component; Defective Component

  MATERIAL # UNKNOWN AND BATCH # UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CORING WITH BD BLUNT TIP NEEDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375255 ↗
• MalfunctionJan 27, 2025Device 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 21241156 ↗
• MalfunctionDec 6, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 305060 BATCH NUMBER#: 4250612 IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PLEASE SEE THE PRODUCT COMPLAINT BELOW AND PICTURES ATTACHED. THIS HAS BEEN REPORTED TO OUR INTERNAL TEAM UNDER CASE. (B)(4). (B)(4) 1EA LOT NUMBER 4250612 CUSTOMER COMMENTS: THE STAFF IN XX PULLED ITEM 305060 FROM THE BINS AND NOTIFIED US THAT IT WAS DIRTY INSIDE THE UNOPENED PACKAGING. CAH PO ORDERED ON IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860366 ↗
• MalfunctionOct 29, 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 20559879 ↗
• MalfunctionOct 21, 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 20500004 ↗
• MalfunctionAug 22, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024547 ↗
• MalfunctionAug 15, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIAL # 305060 BATCH # 4025439. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 3ML SYRINGE WAS USED TO DRAW UP IV MEDICATION. UPON WASTING THE MEDICATION, REGISTERED NURSE (RN) NOTICED THE SYRINGE DID NOT HAVE ANY VOLUME MARKINGS. PRODUCT NUMBER - 305060. LOT NUMBER - 4025439. ADDITIONAL INFORMATION PROVIDED: 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. ACCORDING TO THE MEDICAL RECORD AND INFORMATION OBTAINED, THERE WAS NO PATIENT HARM, COMPLICATION OR NEGATIVE OUTCOMES. 2. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. ACCORDING TO INFORMATION OBTAINED, THERE WERE NO PICTURES TAKEN OR AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996254 ↗
• MalfunctionAug 13, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975794 ↗
• MalfunctionAug 12, 2024Crack; Crack

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ONE OF OUR INTERMOUNTAIN FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. SITUATION: ISSUE: PLASTIPAK 3ML SYRINGE BARREL CRACKED, BLOOD LEAKING DURING BLOOD DRAW. BACKGROUND: EVENT DATE: 7/15/2024. IH #: 93021798 MFG #: 305060 DESCRIPTION: SYRINGE 3ML 18GAX1.5 BLUNT FILL L/L TIP. SAMPLE AVAILABLE: NO SAMPLE OR PHOTOS ARE AVAILABLE FOR THIS EVENT. LOT #: 4031508 ASSESSMENT: CREDIT REQUESTED NO WAS THERE INJURY? NO NAME OF FACILITY : MAIN CONTACT NAME AND PHONE NUMBER: SELF. FRONTLINE CAREGIVERS CONTACT INFORMATION (IF APPLICABLE): NA ACCOUNT # PO PURCHASED ON: (B)(4). RECOMMENDATION/REQUEST: THERE IS NO SAMPLE OR PHOTO AVAILABLE FOR THIS EVENT, REPORTING PURPOSE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959643 ↗
• MalfunctionJul 26, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIAL #: 305060 BATCH #: 4151555 IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: BD 3ML LL SYRINGE W/ BLUNT CANNULA MFG. 305060 LOT 4151555, MISSING/PARTIAL GRADUATIONS SYRINGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19845706 ↗
• MalfunctionJul 26, 2024

  3ML SYRINGE WAS USED TO DRAW UP IV MEDICATION. UPON WASTING THE MEDICATION, REGISTERED NURSE (RN) NOTICED THE SYRINGE DID NOT HAVE ANY VOLUME MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836777 ↗
• MalfunctionJan 26, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIAL#: 305060 LOT#: 3173932. IT WAS REPORTED BY THE CUSTOMER THAT THE RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE FOUND SEVERAL SYRINGES THAT WERE NOT STAMPED CORRECTLY DURING PRODUCTION. IT APPEARS THEY HAVE ALL CAME FROM LOT # 3173932. I HAVE INCLUDED A PHOTO OF THE SYRINGE MISSING ALL THE LINES AND PARTIAL OF THE NUMBERS AND THE FRONT OF A PACKAGE WITH ALL THE LOT # AND INFO NEEDED. I CURRENTLY HAVE 14 THEY CAME FROM SEVERAL DIFFERENT PACKAGED BOXES BUT ALL THE SAME LOT NUMBER SO FAR. I KNOW THERE WERE A FEW THAT WERE THROWN AWAY THINKING IT WAS A FLUKE ISSUE UNTIL WE DISCOVERED IT WAS HAPPENING MORE. PRODUCT: BF305060~TPMECC, PRODUCT NAME: SYRINGE 3ML LUER-LOK W/BLUNT, FILL NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587456 ↗
• MalfunctionDec 9, 2023Crack; Crack

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298345 ↗
• MalfunctionNov 20, 2023Missing Information; Missing Information

  IT WAS REPORTED THE THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL SYRINGES HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL SYRINGES HAVE BEEN FOUND WITHOUT MARKINGS ON THEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179359 ↗

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-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-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-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-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-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