BD Luer-Lok 305064Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382903050642), received between Aug 3, 2018 and Aug 11, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212157 ↗
• MalfunctionNov 4, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE BD SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305064. BATCH#: 5216331. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 3050694. QUANTITY AFFECTED: 1 EACH. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4) ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ACCIDENTALLY POKED BY A NEEDLE FROM A SEALED SYRINGE- AND-NEEDLE COMBO PACKAGE. THE EXPOSURE OCCURRED WHEN HANDLING THE UNOPENED PACKAGE, AND THE NEEDLE PUNCTURED THROUGH THE PACKAGING, RESULTING IN A NEEDLESTICK INJURY. CUSTOMER DISPOSITION REQUEST: LOG ONLY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23468830 ↗
• MalfunctionJun 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BD SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL PACKAGING WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305064. BATCH#: 5043395. IT WAS REPORTED BY CUSTOMER THAT THE PEEL POUCHES ARE NOT SEALED UPON RECEIPT TO THE CUSTOMER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 305064. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PEEL POUCHES ARE NOT SEALED UPON RECEIPT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322937 ↗
• MalfunctionJun 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BD SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL PACKAGING WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305064. BATCH#: 5043395. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 305064. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PEEL POUCHES ARE NOT SEALED UPON RECEIPT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322866 ↗
• MalfunctionJun 23, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BD SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL PACKAGING WAS DAMAGED /DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305064, BATCH#: 5043395. RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 305064, QUANTITY AFFECTED: 1 CASE, SERIAL/LOT NUMBER: (B)(6), PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PEEL POUCHES ARE NOT SEALED UPON RECEIPT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311902 ↗
• MalfunctionFeb 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 21485286 ↗
• MalfunctionJul 8, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690819 ↗
• MalfunctionMay 22, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL: 305064, BATCH#: 3310892 . IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM IS VISIBLY DIRTY INSIDE STERILE PACKAGE BEFORE BEING OPENED.". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM IS VISIBLY DIRTY INSIDE STERILE PACKAGE BEFORE BEING OPENED. CUSTOMER DID NOT SPECIFY THE QUANTITY AFFECTED; UNKNOWN, SAMPLE AVAILABLE, SUPPLIER PLEASE SEND CUSTOMER SAMPLE RETURN INSTRUCTIONS. CAT# OF PRODUCT BEING COMPLAINED: BD305064. DESCRIPTION OF PRODUCT: NEEDLE BLUNT FILL 18GX1.5IN W/LL 10ML SRNG 100EA/BX 4BX/CA. LOT OR S/N: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375470 ↗
• MalfunctionMay 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD BLUNT FILL AND BLUNT FILTER NEEDLE THE PLUNGER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DID DISCOVER THAT ONE OF THE PLUNGERS HAD A VISIBLE DEFECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019899 ↗
• MalfunctionMay 5, 2023Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL PLUNGER IS POSSIBLY LEAKING AND CHANGING COLOR OF THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGERS ARE POSSIBLY LEACHING AND CHANGING THE COLOUR OF THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882394 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL NEEDLE WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305064, BATCH NO: 0288468. IT WAS REPORTED THAT THE CUSTOMER HAS A DEFECTIVE NEEDLE - BLUNT NEEDLE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11341470 ↗
• MalfunctionOct 1, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT SHARPS COLL SLIDE CLOSE CHEMO 9GAL HAD A DAMAGED/OPEN UNIT PACKAGE THAT COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SHIELD WAS MISSING CAUSING A NEEDLE STICK . EVENT DESCRIPTION STATES: THE CUSTOMER RECEIVED A BOX OF 100 EA BUT ONE OF THE SYRINGES WAS OPEN. PRODUCT WAS RECEIVED AND SHIPPED BY CARDINAL IN A SEALED BOX FROM THE VENDOR. UPON RE-STOCKING THIS PRODUCT INSIDE THE PYXIS THE BOX WAS OPEN AND THE PRODUCT TAKEN OUT TO PLACE INSIDE THE BIN. ONCE ALL THE PRODUCT WAS IN THE BIN THE STAFF PRESSED DOWN ON THE PRODUCT IN THE BIN TO COMPACT IT INSIDE THE BIN, WHEN HE WAS PRICKED BY THE NEEDLE ATTACHED TO THE SYRINGE IN THE PACKAGING. PLEASE INVESTIGATE THE CASE AND FORWARD A WRITTEN RESPONSE INCLUDING THE RESULTS OF YOUR INVESTIGATION DIRECTLY TO THE CUSTOMER PLEASE CONTACT OUR CUSTOMER DIRECTLY TO ARRANGE FOR A PRODUCT SAMPLE OF THE DEFECTIVE PRODUCT TO BE RETURNED TO YOU DIRECTLY AND FOR ANY ADDITIONAL INFORMATION YOU MAY NEED. IF ALL THE PRODUCT WAS RETURNED TO CARDINAL HEALTH WITHOUT THE CUSTOMER KEEPING A SAMPLE, PLEASE CONTACT OUR CUSTOMER SERVICE REP (CSR) TO ARRANGE FOR THE PRODUCT TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613200 ↗
• MalfunctionDec 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MEDICATION LEAKED PAST THE SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL PLUNGER DURING USE. LOT# 9269901 WAS REPORTED TO HAVE HAD 118 OCCURRENCES OF THE EVENT, WHILE LOT# 9155510 HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECENTLY, WE HAVE HAD NUMEROUS INSTANCES OF DRUG FLUID LEAKING FROM THE SYRINGE INTO THE SPACE BETWEEN THE FIRST AND SECOND RIBS OF THE PLUNGER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396640 ↗
• MalfunctionOct 3, 2019Leak/Splash; Leak/Splash

  MATERIAL NO: 305064, BATCH NO: 9205240 . IT WAS REPORTED BEFORE USE OF THE SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL THE NEEDLE ON SYRINGE IS LOOSE AND UNABLE TO TIGHTEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, 50% OF THEM BLUNTED NEEDLES WERE ON THE SYRINGE LOOSELY, BUT CAN BE TIGHTEN MANUALLY (THIS REQUIRED AN ADDITIONAL ¼ TURN TO TIGHTEN) TO BE USED. OUT OF THE 50 % OF THE SYRINGES THAT HAD ISSUES: THE OTHER 50% OF THEM THE BLUNTED NEEDLE WERE ON THE SYRINGE LOOSELY, BUT CANNOT BE TIGHTEN MANUALLY, AND CANNOT BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9151684 ↗
• MalfunctionAug 8, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL CAUSED A SERIOUS INJURY IN THE FORM OF A CHANGE IN THE COURSE OF TREATMENT WHICH WAS DETERMINED NECESSARY PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN PREPARATION FOR PERFORMING SPINAL ANESTHESIA IN THE PATIENT IT WAS FOUND THAT THE NEEDLE WAS WITHOUT THE STYLET, AND IT IS NOT POSSIBLE TO USE THE MATERIAL, WE NEED TO INTERRUPT THE PROCEDURE TO FIND ANOTHER MATERIAL, DELAYING THE BEGINNING OF SURGERY.

  Patient problems: Injury

  MAUDE report 8875000 ↗
• MalfunctionMar 14, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND INSIDE OF BD SYR¿10ML LL W/NDL 18X1-1/2 BLUNT FILL. REPORTED BY CUSTOMER: "WE RECENTLY HAD A SAFETY SOS FOR AN ITEM THAT MAY HAVE HAD SOME PLASTIC IN IT. IT WAS A 10ML LUER SYRINGE COMBO WITH BLUNT FILL 18G X 1 ½¿ NEEDLE (305064), LOT NUMBER 8266928. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8421932 ↗
• MalfunctionJan 14, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT "MORE THAN 50" OF THE BD LUER-LOK¿ BLUNT FILL NEEDLES WERE FOUND RIGHT OUT OF THE PACKAGING WITH NO SCALE MARKINGS ON THE SYRINGES, BEING "COMPLETELY CLEAR NO WRITING ON IT AT ALL".

  Patient problems: No Information

  MAUDE report 8244477 ↗
• MalfunctionNov 19, 2018Moisture Damage

  IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK BLUNT FILL NEEDLE THAT THERE WAS MOISTURE ON THE STOPPER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085938 ↗
• MalfunctionNov 9, 2018Dull, Blunt

  IT WAS REPORTED THAT BEFORE USE OF THE BD¿ LUER-LOK¿ BLUNT FILL NEEDLE THAT THERE WAS MOISTURE ON THE STOPPER ATTACHED WITH THE PLUNGER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056803 ↗
• MalfunctionAug 3, 2018Device Contamination with Chemical or Other Material

  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. 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 7747645 ↗

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-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-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-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-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-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