N/A 302832Recalls & reported problems

Summary

The FDA's MAUDE database contains 424 adverse event reports that list this exact device (DI 00382903028320), received between Oct 26, 2017 and Sep 28, 2026 — classified as 424 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (135 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 424 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Contamination

  It was reported, Syringe 30 ML LL, contaminants in syringe.The following was provided by the initial reporter: I had previously sent back a handful of 50ml syringes for evaluation due to contaminants. I have two more syringes I would like a label for that I can return. 30ml syringe - Lot 6138804, exp 04/30/2031. Date noticed 9/9/2026 Both were noticed by our pharmacy department before drawing up medications and were not associated with any patients.additional information:There are multiple contaminants that are a concern for the sterility of the syringe as well as a concern that they could then be injected into the patient. Some are white and some are brown, they are small and are a liquid or a solid. They are all pieces of gunk inside the syringe where fluid would go.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914058 ↗
• MalfunctionSep 16, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793767 ↗
• MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793488 ↗
• MalfunctionSep 14, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765277 ↗
• MalfunctionSep 13, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747883 ↗
• MalfunctionSep 4, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612854 ↗
• MalfunctionSep 3, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589726 ↗
• MalfunctionSep 3, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589696 ↗
• MalfunctionAug 4, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129477 ↗
• MalfunctionJun 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED, SYRINGE 30ML LL S/C, FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT ALL OF THEIR IG1000 IRRIGATION TRAYS SEEM TO HAVE SMALL PARTICLES OF PLASTIC AND FLUID WITHIN THE SYRINGE, SEEMS TO BE A DUST WITHIN THE ENTIRE SEALED PACKAGE. ADDITIONAL INFORMATION: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 01-04-2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503872 ↗
• MalfunctionMay 29, 2026Contamination

  IT IS REPORTED, SYRINGE 30ML LL S/C 56 , SYRINGE HAS SOME SORT OF FLUID IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331666 ↗
• MalfunctionMay 27, 2026Contamination

  IT IS REPORTED, SYRINGE 30 ML, EXTRINSIC PARTICULATE (CERUMEN - EARWAX) OBSERVED IN FINAL PRODUCT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306527 ↗
• MalfunctionMay 25, 2026Leak/Splash

  IT IS REPORTED, BD SYRINGE 30 ML, LEAKING AT THE BLACK SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272402 ↗
• MalfunctionMay 21, 2026Contamination

  IT WAS REPORTED, SYRINGE 30ML LL, BY THE CUSTOMER THAT HAVE A LAYER OF GREASE ON THE INNER PLUNGER/BARREL. ADDITIONAL INFORMATION ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO TOTAL NUMBER OF OCCURRENCES? 2 EACH HAVE BEEN SEEN WITH EXCESS GREASE MATERIAL ON THE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242058 ↗
• MalfunctionMay 12, 2026Contamination

  IT IS REPORTED, LOOSE WHITE PARTICLE, TOWARDS LUER OF SYRINGE. THREE OCCURRENCES.NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151557 ↗
• MalfunctionMar 2, 2026

  WHILE PREPARING A DOSE, THE IV TECHNICIAN DISCOVERED A 30 ML SYRINGE WITH DEBRIS EMBEDDED INSIDE. NO DOSE MADE WITH IT. MOC [MANAGER ON CALL] CONTACTED. COLLECTED AFFECTED SYRINGE AND WILL SAVE FOR COLLECTION/EVALUATION. IV TECHNICIANS WILL CONTINUE TO MONITOR. MANUFACTURER LETTER OF INVESTIGATION AND PHOTO ADDED TO THIS REPORT. BD 30 ML SYRINGE LUER-LOK TIP - EMBOUT BD LUER-LOK, (B)(4), EXP: 2030-05-31, LOT: 5176260. MANUFACTURER RESPONSE FOR 30 ML SYRINGE LUER-LOK TIP, 30 ML SYRINGE LUER-LOK TIP - EMBOUT BD LUER-LOK (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477525 ↗
• MalfunctionFeb 27, 2026Contamination

  NO HARM OR NEGATIVE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472049 ↗
• MalfunctionFeb 6, 2026Contamination

  IT IS REPORTED FOREIGN MATTER. DESCRIPTION: IT WAS REPORTED BY CUSTOMER THAT WE ARE FINDING BLACK FLOATIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278705 ↗
• MalfunctionFeb 2, 2026Break

  THIS COVERS EVENT 2 OF 2. IT IS REPORTED BROKEN PLUNGER. DESCRIPTION: SYRINGE IS BEING USED TO INJECT OMNIPAQUE 240 DURING THE PROCEDURE. THIS HAS BEEN A COMMON PRACTICE WITH NO HARM UNTIL VERY RECENTLY. THE PHYSICIAN HAS BEEN POKED BY THE BROKEN PIECES FROM THE SYRINGE PLUNGER BREAKING. TODAY ((B)(6) 2026) WAS THE THIRD TIME THE SYRINGE BROKE, THE FIRST TIME HAD NO HARM AND THE NEXT TWO TIMES THE PHYSICIAN WAS POKED BY THE NEEDLE; THIS IS THE SAME PROVIDER EACH TIME. WAS PATIENT OR END-USER INJURED: Y. WHEN WAS INCIDENT NOTICED: DURING USE. WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y. WAS ANY MEDICAL TREATMENT REQUIRED: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235268 ↗
• MalfunctionFeb 2, 2026Break

  THIS COVERS EVENT 1 OF 2. IT IS REPORTED BROKEN PLUNGER. DESCRIPTION: SYRINGE IS BEING USED TO INJECT OMNIPAQUE 240 DURING THE PROCEDURE. THIS HAS BEEN A COMMON PRACTICE WITH NO HARM UNTIL VERY RECENTLY. THE PHYSICIAN HAS BEEN POKED BY THE BROKEN PIECES FROM THE SYRINGE PLUNGER BREAKING. THE FIRST TIME HAD NO HARM. WHEN WAS INCIDENT NOTICED: DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234970 ↗
• MalfunctionJan 22, 2026Contamination /Decontamination Problem

  NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147531 ↗
• MalfunctionDec 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302832. BATCH #5212060. VERBATIM: AS PER THE REPORT: RN WENT TO ADMINISTER DOXORUBICIN THAT WAS MADE FROM PHARMACY. NURSE WENT TO PUSH THE MEDICATION INTO PATIENTS IV. DOXOUBICIN SPILLED OUT OF THE OTHER SIDE OF THE SYRINGE AND SPILLED ONTO THE BLANKET THAT THE PATIENT HAD ON HIM. ANOTHER REPORT STATED: PRIMARY RN GAVE DOXORUBICIN IV PUSH VIA MEDIPORT WITH GOOD BLOOD RETURN. UPON COMPLETION OF FIRST SYRINGE OF DOXORUBICIN, PRIMARY RN PLACED SYRINGE IN CHEMO BIN. PT NOTICED ORANGE TINT ON HER SHOE. PRIMARY RN PRESUMED TINT TO BE DOXORUBICIN SPILL. THE IMPACTED PRODUCT IS SEQUESTERED AND WE WOULD LIKE TO SEND IT BACK FOR A QUALITY REVIEW. CAN YOU PLEASE ADVISE NEXT STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797856 ↗
• MalfunctionDec 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302832 BATCH #5212060. AS PER THE REPORT: RN WENT TO ADMINISTER DOXORUBICIN THAT WAS MADE FROM PHARMACY. NURSE WENT TO PUSH THE MEDICATION INTO PATIENTS IV. DOXOUBICIN SPILLED OUT OF THE OTHER SIDE OF THE SYRINGE AND SPILLED ONTO THE BLANKET THAT THE PATIENT HAD ON HIM. ANOTHER REPORT STATED: PRIMARY RN GAVE DOXORUBICIN IV PUSH VIA MEDIPORT WITH GOOD BLOOD RETURN. UPON COMPLETION OF FIRST SYRINGE OF DOXORUBICIN, PRIMARY RN PLACED SYRINGE IN CHEMO BIN. PT NOTICED ORANGE TINT ON HER SHOE. PRIMARY RN PRESUMED TINT TO BE DOXORUBICIN SPILL. THE IMPACTED PRODUCT IS SEQUESTERED AND WE WOULD LIKE TO SEND IT BACK FOR A QUALITY REVIEW. CAN YOU PLEASE ADVISE NEXT STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797855 ↗
• MalfunctionNov 26, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302832 LOT #5176263 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC XXX ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO ITEM: 302832 QUANTITY AFFECTED: 1EA SERIAL/LOT NUMBER: 5176263 PO : 4519197473 ARE ANY SAMPLES AVAILABLE FOR RETURN? YES ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? NO REPORTED ISSUE: I OPENED A STERILE SYRINGE AND NOTICED THERE WAS A BROWNISH SMEAR ON THE INSIDE OF THE SYRINGE (TOWARDS THE PLUNGER END). I HAD JUST CHANGED INTO CLEAN GLOVES AND HAD NOT MOVED THE PLUNGER. I SAW IT AS SOON AS I REMOVED THE WRAPPER. I WAS INSTRUCTED TO PEEL-PACK BOTH THE SYRINGE AND THE WRAPPER IT CAME IN. PLEASE INCLUDE OUR INTERMOUNTAIN CASE NUMBER, (B)(4), WITH ALL EMAIL COMMUNICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656420 ↗
• MalfunctionNov 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 302832. BATCH#: 5154021. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. THIS LOT IN STERILE WRAP HAS BROWN STAINING BY PLUNGER PRODUCT CODE# 302832 LOT# 5154021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616601 ↗

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-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-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-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-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-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