N/A 309649Recalls & reported problems

Summary

The FDA's MAUDE database contains 216 adverse event reports that list this exact device (DI 00382903096497), received between Nov 30, 2017 and Sep 22, 2026 — classified as 4 injuries, 212 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (53 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 216 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860029 ↗
• MalfunctionSep 4, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614124 ↗
• MalfunctionApr 14, 2026Crack

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C BARREL CRACKED. VERBATIM: "LEAKAGE FROM SYRINGE DUE TO CRACK IN THE PLASTIC" DEFECT OBSERVED DURING OR AFTER USE. SAMPLES CONTAMINATED WITH CYTOTOXIC MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873632 ↗
• MalfunctionMar 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C BARREL BOWED. VERBATIM: I'M GOING TO DRAW SAMPLES FROM THE UMBILICAL VENOUS CATHETER AND WHEN I'M ABOUT TO ASPIRATE, I NOTICE THAT THE SYRINGE I'M USING CHANGES SHAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640127 ↗
• MalfunctionMar 9, 2026Packaging Problem

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C PACKAGE WAS DAMAGED / DEFECTIVE. SUPPLIER REFERENCE: 309649. LOT NO.: 5317381. INCIDENT DATE: 02/17/2026. IT WAS REPORTED THAT "DURING USE, A SEALING DEFECT WAS OBSERVED ON THE SYRINGE PACKAGING, WHICH WAS NOT COMPLETELY SEALED. IN ADDITION, THE PRE-CUTS WERE POORLY MADE. THIS ANOMALY ONLY AFFECTS A FEW UNITS IN THE BOX".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546300 ↗
• MalfunctionFeb 27, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C CONTAINED VISIBLE SILICONE. IT LOOKS LIKE MOISTURE OR SOMETHING ELSE AND THE PHARMACY IS NOT SURE TO PREPARE MEDICATION WITH THESE SYRINGES. THE CUSTOMER SAID, IT SEEM´S LIKE MOISTURE, BUT SHE DON¿T KNOW IT. THE LIQUID WAS SEEN ABOVE THE PLUNGER AND INSIDE THE SYRINGE BODY. THE SAMPLES ARE ON THE WAY AND WILL BE EXAMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469927 ↗
• MalfunctionFeb 27, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C CONTAINED VISIBLE SILICONE. IT LOOKS LIKE MOISTURE OR SOMETHING ELSE AND THE PHARMACY IS NOT SURE TO PREPARE MEDICATION WITH THESE SYRINGES. THE CUSTOMER SAID, IT SEEM´S LIKE MOISTURE, BUT SHE DON'T KNOW IT. THE LIQUID WAS SEEN ABOVE THE PLUNGER AND INSIDE THE SYRINGE BODY. THE SAMPLES ARE ON THE WAY AND WILL BE EXAMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469921 ↗
• MalfunctionFeb 27, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C CONTAINED VISIBLE SILICONE. VERBATIM: IT LOOKS LIKE MOISTURE OR SOMETHING ELSE AND THE PHARMACY IS NOT SURE TO PREPARE MEDICATION WITH THESE SYRINGES. THE CUSTOMER SAID, IT SEEMS LIKE MOISTURE, BUT SHE DON¿T KNOW IT. THE LIQUID WAS SEEN ABOVE THE PLUNGER AND INSIDE THE SYRINGE BODY. THE SAMPLES ARE ON THE WAY AND WILL BE EXAMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469915 ↗
• MalfunctionFeb 20, 2026Crack; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406789 ↗
• MalfunctionFeb 13, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 5ML LL EURO 125 S/C CONTAINED FOREIGN MATTER. VERBATIM: I WORK IN THE PEDIATRIC DEPARTMENT AT (B)(6) HOSPITAL, AND WE HAVE FOUND A LUER LOCK SYRINGE THAT HAS SOME KIND OF SPOTS, EVEN THOUGH IT IS STERILELY PACKAGED. I AM ATTACHING PICTURES WITH THE BATCH NUMBER AS WELL AS PICTURES OF THE SPOTS. THERE ARE TWO BROWNISH SPOTS IN TWO DIFFERENT PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338833 ↗
• MalfunctionJan 4, 2026Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? UNKNOWN. IT WAS REPORTED THAT CUSTOMER HAVE FOUND A NUMBER (9) OF PRIMARY PACKAGING UNITS OF BD 5 ML SYRINGES WITH LUER LOCK TIPS, REF. 309649, THAT ARE NOT (PROPERLY) SEALED. THE PLASTIC IS NOT ¿STUCK¿ TO THE PAPER, WHICH MEANS THAT STERILITY CAN NO LONGER BE GUARANTEED. THIS CONCERNS BATCH NO. 4297890, (EXP. 30/09/2029). I HAVE THE SYRINGES IN QUESTION ON MY DESK, SO WE CAN SEND THEM TO BD IF NECESSARY. I WOULD APPRECIATE HEARING WHAT YOU EXPECT ME TO DO IN THIS MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953912 ↗
• MalfunctionJan 4, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SILICONE DROPLETS IN SYRINGE. AFTER THE PATIENT HAS RECEIVED HEAVY WATER IN THE EYE, A BUBBLE IS SEEN IN THE SYRINGE. IT IS NOT AIR BUT LOOKS LIKE SILICONE OIL. THE SYRINGE IS KEPT, AND A RANDOM IDENTICAL SYRINGE IS UNPACKED TOGETHER WITH CHIEF PHYSICIAN (B)(6); IA DROPLET IS CLEARLY VISIBLE ON THE BLACK MEMBRANE. DURING USE: THE INCIDENCE HAS CAUSED NO HARM TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953899 ↗
• MalfunctionDec 24, 2025Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE, IT WAS RECOGNIZED THAT BD SYRINGE 5ML LL CONTAINED FOREIGN MATTER. 1X BD LUER-LOK SYRINGE 5ML, LOT 5072215, REASON: CONTAMINATION IN THE PLASTIC AT THE BOTTOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888210 ↗
• MalfunctionDec 23, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23884027 ↗
• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823933 ↗
• MalfunctionNov 26, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655586 ↗
• MalfunctionNov 26, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECT SKU: 309649. WHEN DID THE INCIDENT OCCUR? BEFORE USE. WE HAVE RECEIVED A COMPLAINT FROM A CUSTOMER WITH REGARDS TO SYRINGE 5ML USA WE PURCHASE FROM YOU, THIS IS WHAT THEY SAY: (DESCRIPTION OF FAULT: THE ITEM HAS ARRIVED, AND IT HAS GREASE/OIL INSIDE OF THE SYRINGE FRESH OUT OF THE PACKET AND IT SHOULD NOT HAVE THIS.) OUR PRODUCT INVESTIGATION TEAM HAVE CHECKED A COUPLE SAMPLES FROM DIFFERENT DELIVERIES/LOT CODES. ALL HAVE SOME FORM OF RESIDUE ON THE BLACK TOP OF THE PLUNGER AS PER ATTACHED IMAGES. BELOW IS AN IMAGE FROM THE CUSTOMER OF THE EFFECT IT HAS FOR THEM. COULD YOU PLEASE CONFIRM WHAT THIS RESIDUE IS PLEASE? IS THIS A NORMAL OCCURRENCE OR SHOULD STOCK BE REMOVED FROM SALE? WHEN WE SEND OUT THE SYRINGE TO OUR CUSTOMER ON A REGULAR BASIS THEY ARE STILL SEALED IN THE WRAPPER THEY ARRIVE IN SO WE WOULD NOT KNOW OR SEE IF ANYTHING WAS WRONG. ADDITIONAL INFO ON 11/11/2025 LOT NUMBERS AFFECTED 4352947, 5035795, 5072216 & 5211978.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655585 ↗
• MalfunctionNov 26, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655581 ↗
• MalfunctionNov 26, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECT SKU 309649 WHEN DID THE INCIDENT OCCUR? BEFORE USE WE HAVE RECEIVED A COMPLAINT FROM A CUSTOMER WITH REGARDS TO SYRINGE 5ML USA WE PURCHASE FROM YOU, THIS IS WHAT THEY SAY: ( DESCRIPTION OF FAULT: THE ITEM HAS ARRIVED, AND IT HAS GREASE/ OIL INSIDE OF THE SYRINGE FRESH OUT OF THE PACKET AND IT SHOULD NOT HAVE THIS. ) OUR PRODUCT INVESTIGATION TEAM HAVE CHECKED A COUPLE SAMPLES FROM DIFFERENT DELIVERIES/LOT CODES. ALL HAVE SOME FORM OF RESIDUE ON THE BLACK TOP OF THE PLUNGER AS PER ATTACHED IMAGES. BELOW IS AN IMAGE FROM THE CUSTOMER OF THE EFFECT IT HAS FOR THEM. COULD YOU PLEASE CONFIRM WHAT THIS RESIDUE IS PLEASE? IS THIS A NORMAL OCCURRENCE OR SHOULD STOCK BE REMOVED FROM SALE? WHEN WE SEND OUT THE SYRINGE TO OUR CUSTOMER ON A REGULAR BASIS THEY ARE STILL SEALED IN THE WRAPPER THEY ARRIVE IN SO WE WOULD NOT KNOW OR SEE IF ANYTHING WAS WRONG. ADDITIONAL INFO ON 11/11/2025: LOT NUMBERS AFFECTED 4352947, 5035795, 5072216 & 5211978.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655577 ↗
• MalfunctionNov 13, 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 23550234 ↗
• MalfunctionNov 5, 2025Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479987 ↗
• MalfunctionAug 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE SKU W/ VISIBLE PARTICLES, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. WHEN DID THE INCIDENT OCCUR? BEFORE USE. PLEASE NOTE THAT WE HAVE IDENTIFIED SEVERAL QUALITY DEFECTS IN THE SYRINGES RECEIVED UNDER (B)(4). THE ISSUES OBSERVED INCLUDE: VISIBLE PARTICLES INSIDE THE SYRINGE. PARTICLES BETWEEN THE PLUNGER AND BARREL SPACE. MULTIPLE WHITE PARTICLES FOUND INSIDE THE PACKAGING. DEFECTIVE PLUNGERS. EXCESSIVE LUBRICANT. THE DETAILS OF THE REJECTED ITEMS CAN BE FOUND IN THE TABLE BELOW, AND SUPPORTING PHOTOGRAPHS ARE ATTACHED FOR YOUR REFERENCE. REF NO. DESCRIPTION SIZE LOT NO QTY RECEIVED TOTAL QTY RECEIVED IN PCS QTY REJECTED % (B)(4) BD PLASTIPAK SYRINGE 5ML (B)(4) 10BOX=(B)(4) (B)(4) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789616 ↗
• MalfunctionAug 12, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE SKU W/ VISIBLE PARTICLES, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. WHEN DID THE INCIDENT OCCUR? BEFORE USE. PLEASE NOTE THAT WE HAVE IDENTIFIED SEVERAL QUALITY DEFECTS IN THE SYRINGES RECEIVED UNDER (B)(4). THE ISSUES OBSERVED INCLUDE: VISIBLE PARTICLES INSIDE THE SYRINGE, PARTICLES BETWEEN THE PLUNGER AND BARREL SPACE, MULTIPLE WHITE PARTICLES FOUND INSIDE THE PACKAGING, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. THE DETAILS OF THE REJECTED ITEMS CAN BE FOUND IN THE TABLE BELOW, AND SUPPORTING PHOTOGRAPHS ARE ATTACHED FOR YOUR REFERENCE. REF NO. DESCRIPTION SIZE LOT NO QTY RECEIVED TOTAL QTY RECEIVED IN PCS QTY REJECTED % 309649, BD PLASTIPAK SYRINGE, 5ML 4352949, 10BOX=1250 1250, 113 9.0%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789606 ↗
• MalfunctionJul 22, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGES ARE NOT COMPLETELY SEALED/GLUED AND ARE THEREFORE ALREADY OPEN AT THE TOP (PISTON SIDE). THIS MEANS THAT STERILITY IS NOT GUARANTEED, WHICH CAN LEAD TO CONTAMINATION OF STERILE OR ASEPTIC MEDICINAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572265 ↗
• MalfunctionJun 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190172 ↗

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-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-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-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-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