BD Luer-Lok 309631Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903096312), received between Apr 16, 2021 and May 30, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD LUER-LOK NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS DETACHED FROM THE PLASTIC HUB AS WILL BE SHOWN IN THE PHOTO ATTACHED IN THE EMAIL. WHEN DID THE INCIDENT OCCUR? BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19430989 ↗
• MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 SYRINGE 5ML LL W/NDL 22X1-1/2 RB EXPERIENCED LIQUID/MOISTURE/DROPLETS IN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309631 BATCH NO: 0247563. THE SYRINGE HAS A LIQUID INSIDE THE SYRINGE, THEY ARRIVED THIS WAY. UPON OPENING IT ONLY SOME OF THE SYRINGES HAVE A DROPLET INSIDE OF SOME SORT OF LUBRICATE. I NOTICED THIS ON TWO SYRINGES, BUT NOW WITH OUR NEW BOXES I NOTICED THIS ON QUITE A LOT OF SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040431 ↗
• MalfunctionMay 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NDL 22X1-1/2 RB LEAKED DILUENT WHILE RECONSTITUTING THE PFIZER COVID-19 VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FEW VIALS OF PFIZER COVID-19 VACCINES WASTED DUE TO FAULTY SYRINGES. DURING RECONSTITUTION, THE DILUENT LEAKED OUT OF THE SYRINGE BEFORE IT COULD BE INJECTED INTO THE VACCINE VIAL.". ¿ BD SUPPLIED 309631 COMBO CONVENTIONAL - SYRINGE 5ML NEEDLE 22G X 1.5" TO BARDA AS PART OF THE U.S. COVID-19 VACCINATION CAMPAIGN . ¿ THE STATED NEED WAS TO SUPPLY THESE AS PART OF RECONSTITUTION FOR VACCINES. ¿ (B)(4) UNITS OF 306931 WERE SUPPLIED IN JANUARY AND FEBRUARY . ¿ THAT PRODUCT WAS THEN SUPPLIED TO END-USER VACCINATOR SITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826263 ↗
• MalfunctionApr 16, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHILE USING 6 BD LUER-LOK¿ SYRINGE THE SCALE MARKING WERE DISCOVERED TO BE MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED MARKINGS ON SYRINGE ARE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681890 ↗

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-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-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-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-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-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-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-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-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-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