BD Luer-Lok 305618Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 30ML LL TIP CONV PAK · Class 2
Quick summary
This is a BD Luer-Lok syringe with a conventional tip. Most of the 60 reports describe material found on or inside the syringe — waxy or growth-like substance on the plunger, ink marks on the tip — along with leaks and splashes, wrong volume readings, and labeling issues. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00382903056187), received between Nov 5, 2017 and Jul 28, 2026 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (22 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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material22
- Leak/Splash17
- Contamination6
- Contamination /Decontamination Problem6
- Volume Accuracy Problem4
- Device Markings/Labelling Problem2
- Break1
- Contamination of Device Ingredient or Reagent1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient6
- No Patient Involvement2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056680 ↗MalfunctionJan 26, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT THE SYRINGE WITH WAX TYPE MATERIAL ON THE PLUNGER AND BLACK INK MARKS ON THE TIP OF THE SYRINGE AS WELL. I AM OFFICIALLY FILING ANOTHER COMPLAINT FOR 30 CC SYRINGE WITH WAX TYPE MATERIAL ON THE PLUNGER AND BLACK INK MARKS ON THE TIP OF THE SYRINGE AS WELL. THIS TIME THE LOT NUMBER IS DIFFERENT THAN PREVIOUSLY SUBMITTED COMPLAINT LOT: 5112150. WE HAVE DISCARDED THAT LOT: 5112150. THIS SYRINGE WAS NOT USED AND CAUGHT BEFORE FILLING. PLEASE SEE INFORMATION BELOW: ITEM: 30 CC SYRINGE TRAY (BD) QTY: 1 LOT NUMBER: 5183734 MATERIAL ITEM CODE: 305618 SAMPLE IS AVAILABLE FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178882 ↗MalfunctionJan 26, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT THE SYRINGE WITH WAX TYPE MATERIAL ON THE PLUNGER AND BLACK INK MARKS ON THE TIP OF THE SYRINGE AS WELL. VERBATIM: I AM OFFICIALLY FILING ANOTHER COMPLAINT FOR 30 CC SYRINGE WITH WAX TYPE MATERIAL ON THE PLUNGER AND BLACK INK MARKS ON THE TIP OF THE SYRINGE AS WELL. THIS TIME THE LOT NUMBER IS DIFFERENT THAN PREVIOUSLY SUBMITTED COMPLAINT LOT 5112150. WE HAVE DISCARDED THAT LOT 5112150. THIS SYRINGE WAS NOT USED AND CAUGHT BEFORE FILLING. PLEASE SEE INFORMATION BELOW: ITEM: 30 CC SYRINGE TRAY (BD) QTY: (B)(4) LOT NUMBER: 5183734 MATERIAL ITEM CODE: 305618 SAMPLE IS AVAILABLE FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178881 ↗MalfunctionJan 26, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT BD (B)(6) SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT GROWTH/FOREIGN MATERIAL IS ON THE TOP OF PLUNGER. INCIDENT DESCRIPTION: AS PER CLIENT, HAVING THIS GROWTH LIKE MATERIAL AFTER FILLING. IT SHOWS CLOUDINESS AFTER FILLING. IN ONE OF THE PICTURES, IT'S VERY CLEAR THE GROWTH/FOREIGN MATERIAL IS ON THE TOP OF PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178183 ↗MalfunctionJan 23, 2026Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163480 ↗MalfunctionNov 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543592 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23512032 ↗MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075133 ↗MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749955 ↗MalfunctionMar 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS PROVIDED THAT BD SYRINGE 30ML LL TIP CONV PAK FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT IN 30 ML SYRINGE, REJECTED 7 SYRINGES THE WHITE MATERIAL IS ON THE CENTER TOP OF THE PLUNGER. VERBATIM: 1- (B)(6) BROUGHT US REJECTED SYRINGES FROM ONE OF THE CEFAZOLIN 1 G IN NS 25 ML SYRINGE BATCH # 0000521073. IF YOU LOOK AT THE PICTURES ATTACHED THERE IS WHITE FLAKY LIGHT MATERIAL WHICH IS STUCK EITHER ON THE MIDDLE TOP SECTION OF THE PLUNGER OR RIGHT OR LEFT SIDE OF THE PLUNGER. MOREOVER, THERE ARE OTHER TYPE OF PARTICLES STUCK EITHER ON THE INSIDE WALL OF THE SYRINGE BARREL. (B)(6) WE WILL DISCUSS TOMORROW ABOUT THESE 30 CC SYRINGE LOT, MENTIONED ABOVE. THE REJECTION RATE IS HIGH (15 IN A BATCH OF 100). 2- ANOTHER BATCH # 0000521105 CEFTRIAXONE 2 G IN 20 ML STERILE WATER INJ. IN 30 ML SYRINGE, REJECTED 7 SYRINGES, ONE PICTURE ATTACHED AT THE END. THE WHITE MATERIAL IS ON THE CENTER TOP OF THE PLUNGER. CAN BE SEEN WITH ZOOM IN. 3- (B)(6) WE ALSO NEED TO DISCUSS THE PREVIOUS LOT PUT ON HOLD, WHERE FOUND MATERIAL ON TOP OF THE PLUNGER. TESTING WAS DONE ON THAT SYRINGE BY USING EM PLATE AND NO GROWTH WAS OBSERVED. REFER ATTACHED E-MAIL FOR PICTURES TAKEN BEFORE TESTING. ADDITI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710457 ↗MalfunctionJan 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY AND PLASTIC DEBRIS WAS OBSERVED ON THE PLUNGER OF A SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY. PLASTIC DEBRIS WAS OBSERVED ON THE PLUNGER OF A SYRINGE. ITEM - 305618. LOT - 4215192, 4246326.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21265092 ↗MalfunctionDec 3, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833673 ↗MalfunctionOct 15, 2024Missing Information; Missing Information
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK SCALE MARKING ISSUE. IT WAS REPORTED BY CUSTOMER THAT LABELLING ISSUE. ISSUE - LABELLING ISSUE. ITEM: 305618. SHOWN ON OUR WEBSITE WITH OZ AND ML GRADUATION MARKS, BUT OUR CURRENT STOCK HAS THE SYRINGES WITHOUT. IT¿S OKAY IF THERE WAS A CHANGE, WE WOULD JUST LIKE TO KNOW IF THIS SHOULD BE EXPECTED ON ALL FUTURE SHIPMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20455721 ↗MalfunctionOct 10, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418299 ↗MalfunctionAug 5, 2024Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910239 ↗MalfunctionJun 20, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
MalfunctionJun 17, 2024Contamination; Contamination
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT CONTAMINANT IN SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER REPORTED CONTAMINANT IN SYRINGES. PO#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547771 ↗MalfunctionMay 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THE PARTICULATE WAS OBSERVED WITHIN THE FLUID PATH OF BD SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PARTICULATE WAS OBSERVED WITHIN THE FLUID PATH OF BD SYRINGES. THE FOLLOWING EXTRINSIC PARTICLES WERE IDENTIFIED VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR): PAPER. (CELLULOSE) COTTON-RAYON. OLEFIN-NYLON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391908 ↗MalfunctionMay 13, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19300646 ↗MalfunctionApr 3, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT CARDBOARD DEBRIS WAS OBSERVED IN THE BARREL OF A SYRINGE AND AS WELL IN TRAY. VERBATIM: CARDBOARD DEBRIS WAS OBSERVED IN THE BARREL OF A SYRINGE. CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038997 ↗MalfunctionDec 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK LEAKED PAST STOPPER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT 30ML SYRINGE LEAKAGE PAST THE PLUNGER. VERBATIM: 30ML SYRINGE LEAKAGE PAST THE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18422142 ↗MalfunctionOct 17, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED. MAT#:305618 BATCH#: 3150632. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD 5 SYRINGES THAT WERE LEAKING THROUGH THE PLUNGER INSIDE THE BARREL (ALL FROM DIFFERENT PACKS BUT ALL THE SAME LOT). VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF (B)(4). SYRINGE 30ML LL TIP CONV PAK. LOT 3150632. THEY HAD 5 SYRINGES THAT WERE LEAKING THROUGH THE PLUNGER INSIDE THE BARREL (ALL FROM DIFFERENT PACKS BUT ALL THE SAME LOT). 16 OCT 23. PLEASE ADVISE THE OCCURRENCE DATE. (B)(6) 2023 -IS THERE ANY ADVERSE EVENT ON PATIENT? NO, LEAKING WAS OBSERVED BEFORE THE SYRINGES LEFT THE PHARMACY. IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? NO. WHAT IS THE DRUG USED DURING THE INCIDENT? CEFEPIME AND CEFTRIAXONE. DO YOU HAVE PHOTO FOR OUR REVIEW? YES. IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE ADVISE YOUR ADDRESS FOR RETURN LABEL. WE HAVE THE 5 SYRINGES THAT HAVE DRUG IN THEM. WE ALSO HAVE 6 PACKS FROM THE SAME LOT THAT HAVE NOT BEEN OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17950839 ↗MalfunctionOct 10, 2023Contamination; Contamination
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE IN THE BULK STERILE PHARMACY CONVENIENCE TRAY EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAIR FOUND WITHIN BARREL OF SYRINGE, PACK OF BULK SYRINGES WAS OPEN IN POSITIVE PRESSURE CLEAN ROOM. NOT SURE HOW HAIR WOULD HAVE GOT INTO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17908419 ↗MalfunctionJun 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REF#(B)(4) SYRINGES ARE VERY OILY, LOOKS LIKE OIL RESIDUE INSIDE THE SYRINGE AS WELL. CUSTOMER ALSO JUST ADVISED THEY LOCATED A FURTHER 10 IMPACTED DEVICES TODAY ¿ SO THAT IS NOW 30 TOTAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17081597 ↗MalfunctionJun 6, 2023Contamination; Contamination
IT WAS REPORTED THAT 20 BD LUER-LOK¿ SYRINGES BULK STERILE PHARMACY CONVENIENCE TRAY HAD OILY RESIDUE INSIDE THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGES ARE VERY OILY, LOOKS LIKE OIL RESIDUE INSIDE THE SYRINGE AS WELL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17075656 ↗
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, ClassifiedSYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
- Z-2750-2017 · Sep 16, 2016 · TerminatedBD 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-2753-2017 · Sep 16, 2016 · TerminatedBD 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-2751-2017 · Sep 16, 2016 · TerminatedBD 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-2747-2017 · Sep 16, 2016 · TerminatedBD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
- Z-2752-2017 · Sep 16, 2016 · TerminatedBD 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 · TerminatedBD 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-1937-2016 · Mar 25, 2016 · TerminatedHenry 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 · TerminatedHenry 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 · TerminatedBD 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
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.