N/A 302830Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 20ML LL S/C 48 · Class 2
Quick summary
This BD syringe is a piston syringe for drawing up and delivering fluids. Its 458 reports mostly describe contamination of the syringe, leaks or splashes, unclear labels and volumes that are off, with some describing packaging that was not properly sealed. 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
- 462
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 462 adverse event reports that list this exact device (DI 00382903028306), received between Oct 30, 2017 and Sep 29, 2026 — classified as 462 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (153 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 Material153
- Leak/Splash79
- Device Markings/Labelling Problem42
- Volume Accuracy Problem36
- Contamination25
- Contamination /Decontamination Problem24
- Packaging Problem23
- Break21
Patient problems
- No Clinical Signs, Symptoms or Conditions254
- No Known Impact Or Consequence To Patient118
- No Patient Involvement46
- No Consequences Or Impact To Patient32
- Insufficient Information6
- No Information5
- Laceration(s)1
- No Code Available1
Recent adverse event reports
The 25 most recent of 462 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935054 ↗MalfunctionSep 28, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917220 ↗MalfunctionAug 31, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520488 ↗MalfunctionAug 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499286 ↗MalfunctionAug 26, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459566 ↗MalfunctionAug 19, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322828 ↗MalfunctionAug 19, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322822 ↗MalfunctionAug 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194544 ↗MalfunctionAug 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192998 ↗MalfunctionJun 1, 2026Unsealed Device Packaging
IT IS REPORTED, SYRINGE 20ML LL S/C 48, SYRINGE PACKAGE WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354190 ↗MalfunctionMay 11, 2026Contamination; Delivered as Unsterile Product
IT IS REPORTED, SYRINGE 20ML, HAIR WAS OBSERVED IN THE WRAPPER LOCATED WITHIN THE SYRINGE¿S SEALED PORTION AND INSIDE AREA. WE DISCOVERED THIS ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137107 ↗MalfunctionMay 11, 2026Unsealed Device Packaging
IT WAS REPORTED, THE SYRINGE AT THE END IS NOT PROPERLY SEALED AND IS THEREFORE NO LONGER STERILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135914 ↗MalfunctionApr 27, 2026Break
IT IS REPORTED, 20ML BD LUER-LOK SYRINGE, THREADED CENTER PART OF THE SYRINGE BROKE OFF IN THE IV PORT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000157 ↗MalfunctionApr 17, 2026Break; Leak/Splash
IT WAS REPORTED, NURSE NOTED THAT THE BACK OF THE SYRINGE WAS SHATTERED AND MEDICATION WAS LEAKING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912297 ↗MalfunctionApr 9, 2026Contamination
IT WAS REPORTED BY THE CUSTOMER THAT OBSERVED MULTIPLE BLACK, BUBBLED SPECKS EMBEDDED WITHIN THE BARREL OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830238 ↗MalfunctionApr 9, 2026Leak/Splash
IT WAS REPORTED, ALBUMIN WAS LEAKING AROUND THE BLACK PLUNGER PORTION OF THE SYRINGE INTO THE BARREL OF THE SYRINGE BEHIND THE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830234 ↗MalfunctionApr 3, 2026Contamination
IT WAS REPORTED OPENED 20 CC SYRINGE TO DRAW HEPARIN AROUND 1000, PACKAGE WAS INTACT AND FOUND BLACK SPECKS INSIDE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777491 ↗MalfunctionMar 16, 2026Packaging Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE LID, NOT PROPERLY CLOSED, WOBBLES, COMPROMISING STERILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604940 ↗MalfunctionMar 9, 2026Contamination /Decontamination Problem
IT IS REPORTED FOREIGN MATTER. DESCRIPTION: A NURSE NOTICED A PIECE OF BLACK PLASTIC FLOATING INSIDE THE BARREL OF THE SYRINGE WHILE DRAWING MEDS. UPON INSPECTION, THERE WERE A FEW OTHER SEALED SYRINGES THAT CARRY THE SAME LOT WITH VISIBLE CONTAMINATION AS WELL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24545357 ↗MalfunctionFeb 27, 2026Contamination
IT WAS REPORTED BY THE CUSTOMER THAT ITEM IS DIRTY INSIDE SEALED PACKAGE. IT WAS ON BOTH ENDS OF THE PRODUCT STILL INSIDE THE ORIGINAL PACKAGING. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470800 ↗MalfunctionFeb 18, 2026Contamination
20 ML BD SYRINGE HAD A FOREIGN BODY IN IT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378113 ↗MalfunctionFeb 10, 2026Packaging Problem
IT WAS REPORTED BY CUSTOMER THAT BLACK STRIP ON BACK OF PACKAGING, WHEN SEPARATED NOTED THAT NOT SEALED WHERE BLACK STRIP IS PRESENT REPRESENTING CONCERN FOR STERILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304579 ↗MalfunctionJan 1, 2026Leak/Splash
IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 48 HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302830, BATCH#: 5282805. RCC RECEIVED A COMPLAINT VIA EMAIL. THE XXXX LOCATION THINKS THEY RECEIVED A BAD BATCH OF 20ML SYRINGES, THEY ARE ALL LEAKING DOWN PAST THE PLUNGER. SEE INFO AND PICS BELOW. PLEASE ADVISE OF NEXT STEPS. BD, LOT: 5282805, EXP: 9/30/2030. REORDER NUMBER: (B)(4). ADDITIONAL INFORMATION: DATE OF EVENT: 10-12-2025. PATIENT IMPACT: NO IMPACT TO PATIENT, CHANGED OUT SYRINGE IN IV ROOM BEFORE GOING OUT TO ADMINISTER TO PATIENT AT CHAIR SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23939646 ↗MalfunctionJan 1, 2026Crack
IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 48 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302830, BATCH#: UNKNOWN. RCC RECEIVED A COMPLAINT VIA EMAIL. DATE OF INCIDENT: ON (B)(6) 2025. LEVEL OF HARM: INCIDENT DETAILS: WHILE SYRINGE PUMP RUNNING ANTIBIOTIC, IT WAS DISCOVERED THE SYRINGE WAS LEAKING DUE TO A CRACK IN THE SIDE UNDERNEATH THE STICKER. IMPACT OF INCIDENT: WHO WAS AFFECTED? PATIENT. PROCEDURE: NO. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP 20ML. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 302830. SERIAL OR LOT NUMBER: SUPPLIER: (B)(4). SUPPLIER CATALOGUE NUMBER: 308-302830. WAS THE DEVICE RETAINED? NO. NO SERIOUS HARM WAS REPORTED. UNFORTUNATELY, THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. CUSTOMER RESPONSE ON (B)(6) 2025. WE WILL NOT HAVE THE LOT NUMBER AS WE DO NOT HAVE THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23939559 ↗MalfunctionDec 24, 2025Contamination; Contamination
IT WAS REPORTED THAT THERE WAS AN UNKNOWN FOREIGN SUBSTANCE OR SCRATCH ON THE BLACK RUBBER PACKING OF BD SYRINGE 20ML LL S/C 486U4S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888470 ↗
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-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-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-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-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-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-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-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 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
- BD Ultra-Fine 328438Becton, Dickinson and Company Inc · Syringe, piston316 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.