BD Luer-Lok 309634Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903096343), received between Mar 27, 2018 and Dec 7, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT 10 5ML SYRINGES WITH PRECISIONGLIDE¿ NEEDLES EXPERIENCED DAMAGED PACKAGING WHERE THE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RECEIVING DEPARTMENT FOUND THE PARTS FOUND RANDOM SAMPLE OF QUANTITY 10 PACKAGES OF BD SYRINGE WITH OPEN POUCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936582 ↗
• MalfunctionOct 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 5ML SYRINGE WITH PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309634 BATCH NO: 8294971. IT WAS REPORTED THAT THERE WAS SOME SORT OF CONTAMINANT INSIDE OF STERILE SYRINGE. PER CUSTOMER EMAIL: ONE OF OUR LOCATIONS JUST REPORTED FINDING A CONTAMINANT IN A STERILE SYRINGE SHE OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9186085 ↗
• MalfunctionJun 26, 2019Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  MATERIAL NO: 309634 BATCH NO: UNKNOWN IT WAS REPORTED THAT DURING USE OF THE BD¿ LUER-LOK SYRINGE THE GRADUATION MARKS DO NOT STICK WELL AND THERE IS FOREIGN MATTER ON THE SURFACE OF BARREL A WAXY SUBSTANCE. THE NUMBER OF OCCURRENCES ALONG WITH THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DETAILS OF COMPLAINT (REPORTED ISSUE): GLUE PISTON - DOUBTS ABOUT THE RELIABILITY OF GRADUATION - SQUEEGEE DOES NOT GLUE PROPERLY (SURFACE IS AS A CIREUSE BUT IT IS INTERMITTING HANDLING NOT WELL DECREASED SPEED OF DRUG ADMINISTRATION NURSE SAYS THAT WHEN IT TAKES A MEDICINE THERE IS SOME QUANTITY WHEREAS IT DOES NOT ARRIVE BEFORE, IS NOT UNTIL A NON-IDENTIFIER DRUG (TIGHTENING STICK) RESUTE TO A GASPILLE OF MEDICINE / LOSS OF TIME / RISK OF ERROR ( I DO NOT HAVE THE TOTAL QUANTITIES AFFECTED).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8736362 ↗
• MalfunctionDec 28, 2018Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PLUNGERS OF BD¿ LUER-LOK WERE DEFORMED BEFORE USE.

  Patient problems: No Information

  MAUDE report 8204012 ↗
• MalfunctionMar 27, 2018Moisture Damage; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿ TIP HAD MOISTURE AND BLACK FLAKES WITHIN THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374184 ↗

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-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-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-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-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-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-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