BD Luer-Lok 309680Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00382903096800), received between Oct 23, 2017 and Sep 25, 2026 — classified as 1 injury, 145 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (78 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  It was reported by customer that multiple product quality concerns that have been identified with BD sterile syringes from several lots. Verbatim: Complaint via Email. Email attached. I am writing to report multiple product quality concerns that have been identified with BD sterile syringes from several lots currently in our inventory. These issues have been observed across multiple syringes and lot numbers, raising concerns regarding product quality and manufacturing consistency. The defects identified include: Extra measurement markings printed on syringe barrels Black specks present on syringe barrels Unidentifiable debris observed within syringe barrels Missing graduation markings on the barrel The affected products and lot numbers are as follows: 50 mL Sterile Syringes Lot 6138808: Two syringes identified with defects Lot 6098162: Two syringes identified with defects Lot 6098177: Two syringes identified with defects Lot 6131767: 26 Defective syringes identified 5 mL Sterile Syringe Lot 6114407: One syringe identified with missing graduation markings on the side of the barrel These defects were identified during routine inspection. Due to concerns regarding product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899381 ↗
• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  It was reported by customer that multiple product quality concerns that have been identified with BD sterile syringes from several lots. Verbatim: Complaint via Email. Email attached. I am writing to report multiple product quality concerns that have been identified with BD sterile syringes from several lots currently in our inventory. These issues have been observed across multiple syringes and lot numbers, raising concerns regarding product quality and manufacturing consistency. The defects identified include: Extra measurement markings printed on syringe barrels Black specks present on syringe barrels Unidentifiable debris observed within syringe barrels Missing graduation markings on the barrel The affected products and lot numbers are as follows: 50 mL Sterile Syringes Lot 6138808: Two syringes identified with defects Lot 6098162: Two syringes identified with defects Lot 6098177: Two syringes identified with defects Lot 6131767: 26 Defective syringes identified 5 mL Sterile Syringe Lot 6114407: One syringe identified with missing graduation markings on the side of the barrel These defects were identified during routine inspection. Due to concerns regarding product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899380 ↗
• MalfunctionAug 10, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194726 ↗
• MalfunctionMay 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY CUSTOMER THAT ARE SEEING HERE AT OUR FACILITY AS EXCESS SILICONE (DROPLETS OR GLOBS) IN UNFILLED UNITS PRIOR TO USE. THE SILICONE IS PRESENTING AS THOUGH THERE IS MATERIAL OR WHAT WE WOULD CALL ¿PARTICULATE¿ STUCK ON THE SYRINGE STOPPER. THIS IS IDENTIFIED THROUGH OUR VISUAL INSPECTION PROGRAM. BECAUSE WE ARE UNABLE TO DECIPHER REAL TIME IF THESE ARE SILICONE, THESE UNITS ARE REQUIRED TO BE REJECTED IN OUR PROCESS AND EVALUATED BY OUR INTERNAL CHEMISTRY LAB. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WANTED TO SHARE SOME EXAMPLES OF WHAT WE ARE SEEING HERE AT OUR FACILITY AS EXCESS SILICONE (DROPLETS OR GLOBS) IN UNFILLED UNITS PRIOR TO USE. PLEASE SEE THE ATTACHED DOCUMENT (AREAS OF CONCERN ARE CIRCLED IN RED WITH DESCRIPTIONS BELOW EACH PICTURE). THESE EXAMPLES ARE FROM AN UNFILLED BD 50ML SYRINGE LOT 6005434. I AM HOPING YOU CAN HELP ME WITH THE BELOW QUESTIONS: DO YOU PERFORM VISUAL INSPECTION ON ALL UNITS AFTER MANUFACTURING? IF SO, IS EXCESS SILICONE SOMETHING YOUR TEAM LOOKS FOR DURING YOUR VISUAL INSPECTION PROCESS? WHAT ARE THE REQUIREMENTS FOR SILICONE? WOULD THESE SYRINGES MEET YOUR SPECIFICATIONS AND ARE DEEMED AS ACCEPTABLE? THE REASON I AM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186926 ↗
• MalfunctionApr 22, 2026Contamination /Decontamination Problem

  IT IS REPORTED, PARTICULATE IDENTIFIED, SYRINGE 50CC LL TIP CONVENIENCE PAK. THE PARTICULATE WAS ANALYZED BY A CONTRACT LABORATORY AND WAS DETERMINED TO BE A SILICON-RICH MATERIAL WITH IRON INCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955095 ↗
• MalfunctionApr 14, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT INSIDE AND OUTSIDE OF THE SYRINGE BARREL AND BOTH SIDES OF WHITE PARTICULATE WERE LEVEL WITH SYRINGE BARREL SURFACE. COMPLAINT VIA EMAIL. I FELT INSIDE AND OUTSIDE OF THE SYRINGE BARREL AND BOTH SIDES OF WHITE PARTICULATE WERE LEVEL WITH SYRINGE BARREL SURFACE. BD 50 ML SYRINGE LUER-LOK TIP BULK STERILE CONVENIENCE PAK FROM REF 309680 LOT 5308026 EXP 2030-10-31 NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874850 ↗
• MalfunctionApr 13, 2026Contamination; Contamination /Decontamination Problem

  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 24859816 ↗
• MalfunctionApr 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT ONE SYRINGE WAS FOUND TO CONTAIN AN EXTERNAL DEFECT AT THE TOP OF THE PLUNGER. COMPLAINT VIA EMAIL. DURING COMPOUNDING OF LOT 20260323-0AE0DF, HYDROMORPHONE HCL 10 MG IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE-1, ONE SYRINGE WAS FOUND TO CONTAIN AN EXTERNAL DEFECT AT THE TOP OF THE PLUNGER. THIS UNIT IS AVAILABLE FOR RETURN. DETAILS FOR YOUR INVESTIGATION: PRODUCT: STERILE SYRINGE TRAY 50ML LOT NUMBER: 5170561 PART NUMBER: 309680 NUMBER OF DEFECTIVE UNITS: 1 DEFECT TYPE: EXTERNAL DEFECT PRODUCT COMPLAINT: (B)(4) QUANTITY: (B)(4) PLEASE LET ME KNOW THE RESULTS OF THE INVESTIGATION. ADDITIONAL INFORMATION: DATE OF EVENT: 23/MAR/2026."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790428 ↗
• MalfunctionMar 30, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING SYRINGES. VERBATIM: COMPLAINT VIA EMAIL: XXX IS ISSUING A SCAR TO BD FOR LEAKING SYRINGES, SEE ATTACHMENTS FOR MORE DETAILS. PLEASE REACH OUT IF FURTHER INFORMATION IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717151 ↗
• MalfunctionMar 30, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING SYRINGES. VERBATIM: COMPLAINT VIA EMAIL: XXX IS ISSUING A SCAR TO BD FOR LEAKING SYRINGES, SEE ATTACHMENTS FOR MORE DETAILS. PLEASE REACH OUT IF FURTHER INFORMATION IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716139 ↗
• MalfunctionMar 9, 2026Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551441 ↗
• MalfunctionFeb 19, 2026Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389353 ↗
• MalfunctionDec 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT INCOMING AQL INSPECTION IDENTIFIED A LONG FIBROUS PARTICLE WITHIN THE SYRINGE BARREL). THIS WAS LATER IDENTIFIED TO BE A HUMAN HAIR. RCC RECEIVED A COMPLAINT VIA EMAIL. INCOMING AQL INSPECTION IDENTIFIED A LONG FIBROUS PARTICLE WITHIN THE SYRINGE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840217 ↗
• MalfunctionDec 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719013 ↗
• MalfunctionNov 17, 2025Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570665 ↗
• MalfunctionNov 17, 2025Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  MATERIAL # 309680. BATCH # 5160401,4246343. IT WAS REPORTED BY CUSTOMER THAT TWO 50ML SYRINGES HAVE INTERNAL DEFECTS: ONE HAS A WHITE APPEARANCE OTHER ONE HAS A BLACK APPEARANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570292 ↗
• MalfunctionSep 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016598 ↗
• MalfunctionSep 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016580 ↗
• MalfunctionJun 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT "EXTRINSIC PARTICULATE (POLYESTER) WAS FOUND IN THE SYRINGE BARREL AFTER FILLING ACTIVITIES." RCC RECEIVED A COMPLAINT VIA EMAIL. EXTRINSIC PARTICULATE (POLYESTER) WAS FOUND IN THE SYRINGE BARREL AFTER FILLING ACTIVITIES. THE PARTICULATE WAS IDENTIFIED ON 05MAY25. THROUGH INVESTIGATION IT WAS DETERMINED THE MATERIAL WAS LIKELY PRESENT IN THE SYRINGE BARREL PRIOR TO FILLING. SUPPLIER PRODUCT # 309680 MATERIAL DETAILS SYRINGE (STERILE), 50 ML LL, BD TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358750 ↗
• MalfunctionJun 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT UNKNOWN PARTICLES WERE OBSERVED IN TWO SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INCOMING INSPECTION OF SEVERAL LOTS OF 309680 REVEALED TWO DEFECTS. A SYRINGE FROM LOT 4355027 CONTAINED A BLUE FIBER ON THE RUBBER STOPPER WITHIN THE BARREL OF THE ASSEMBLY. A SYRINGE FROM LOT 4355030 SHOWED BLACK PARTICULATES ON THE PLUNGER JUST ABOVE THE RUBBER STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167481 ↗
• MalfunctionJun 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT UNKNOWN PARTICLES WERE OBSERVED IN TWO SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INCOMING INSPECTION OF SEVERAL LOTS OF 309680 REVEALED TWO DEFECTS. A SYRINGE FROM LOT 4355027 CONTAINED A BLUE FIBER ON THE RUBBER STOPPER WITHIN THE BARREL OF THE ASSEMBLY. A SYRINGE FROM LOT 4355030 SHOWED BLACK PARTICULATES ON THE PLUNGER JUST ABOVE THE RUBBER STOPPER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167432 ↗
• MalfunctionMay 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DESCRIPTION/EVENT DETAILS: MATERIAL # 309680 BATCH # 4309754 VERBATIM: FOREIGN MATERIAL, CARDBOARD-LIKE, WAS FOUND INSIDE OF A SYRINGE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070337 ↗
• MalfunctionApr 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT AN EXTRINSIC PARTICULATE FOUND AND WAS IDENTIFIED TO BE A STYRENE ACRYLIC COPOLYMER WITH INCLUSIONS CONTAINING OXYGEN, SILICON, SULFUR, AND BARIUM. RCC RECEIVED A COMPLAINT VIA EMAIL. SUP#: SUP-2025-0011, DATE INITIATED: 01APR2025, SUPPLIER: (B)(4), PRODUCT#: 309680, SCA PART NUMBER: R15028, MATERIAL DETAILS: SYRINGE (STERILE), 50 ML LL, BD TRAY *309680* (20/TRAY; 6 TRAY/CS), MATERIAL LOT NUMBER: 4246339, COMPLAINT DETAILS EXTRINSIC PARTICULATE FOUND AND WAS IDENTIFIED TO BE A STYRENE ACRYLIC COPOLYMER WITH INCLUSIONS CONTAINING OXYGEN, SILICON, SULFUR, AND BARIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868621 ↗
• MalfunctionFeb 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT THERE WAS A INCK SMUG IN SYRINGE. VERBATIM: INCK SMUG IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403902 ↗
• MalfunctionFeb 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT ANOTHER 50ML SYRINGE FROM A TRAY, WITH INK STAINS ON THE PLUNGER. IT'S NOT AS BIG AS A SYRINGE WITH A HAIR/HAIR INSIDE THE PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IT HAPPENED TODAY. I WAS GIVEN ANOTHER 50ML SYRINGE FROM A TRAY, WITH INK STAINS ON THE PLUNGER. IT'S NOT AS BIG AS A SYRINGE WITH A HAIR/HAIR INSIDE THE PLUNGER, BUT I KEPT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401229 ↗

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-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-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-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-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-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