BD Luer-Lok 309585Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382903095859), received between Sep 6, 2019 and Oct 31, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL NO: 309585 BATCH NO: 0053070. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 3ML LL THE SYRINGES WERE RECEIVED WITHOUT EXPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN HAVING MULTIPLE INSTANCES OF NOT HAVING AN EXPIRATION DATE ON THEIR FLUSH SYRINGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9262638 ↗
• MalfunctionSep 6, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 309585 BATCH NO. UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 3ML LL THERE IS SYRINGE NEEDLE CONNECTIVITY ISSUE, SYRINGES ARE LEAKING WHEN USED WITH COVIDIEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS HAS HAPPENED SEVERAL TIMES WITH THE A VISCOUS MEDICATION HOWEVER A NON-VISCOUS MEDICATION WAS USED AND I WAS ABLE TO RECREATE THE LEAK WITH NORMAL SALINE. THE NON-VISCOUS MEDICATION IS ADMINISTERED WITH THE 3ML SYRINGE, HOWEVER THE VISCOUS MEDICATION IS ADMINISTERED FROM A 10ML SYRINGE. I BELIEVE THERE MUST BE AN ISSUE WITH THE 20G 5/8¿ NEEDLE FIT IN THE THREADS OF BD SYRINGES, PARTICULARLY IF THERE IS ANY RESISTANCE OR VISCOSITY TO THE MEDICATION. I DO NOT HAVE A NUMBER OF TIMES, AS IT WAS SHARED WITH ME IN PASSING BY THE NURSING STAFF. I DID FIND OUT IT HAS OCCURRED AT BOTH CAMPUSES OVER SEVERAL MONTHS, THUS MAKING ME BELIEVE IT IS NOT A SPECIFIC LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8970588 ↗

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-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-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-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