BD Luer-Lok 309589Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903095896), received between Jan 29, 2018 and Aug 30, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS DELIVERING INJECTION OF TESTOSTERONE CYPIONATE 200 MG/ML NDC 0143-9659-01. MEDICATION WAS REMOVED FROM THE RX BOTTLE USING THE BD PLASTIPAK 3 ML SYRINGE. PATIENT REMOVED THE NEEDLE FROM THE SYRINGE AND REPLACED IT WITH THE BD SAFETYGLIDE NEEDLED (25G) TO INJECT THE MEDICATION INTO LEFT THIGH. THE MEDICATION WOULD NOT FLOW THROUGH THROUGH THE NEEDLE AND INTO THE INJECTION SITE, DESPITE PUSHING DOWN HARD ONTO THE SYRINGE. PATIENT REMOVE NEEDLE AND FORCED SOME LIQUID THROUGH THE NEEDLE THEN STUCK THE RIGHT THIGH AND WAS ABLE TO FORCE THE LIQUID INTO THE MUSCLE.

  Patient problems: Discomfort

  MAUDE report 17658833 ↗
• MalfunctionFeb 7, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G SCALE MARKINGS WERE MISSING. THIS OCCURRED 30 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABOUT 30 SYRINGES FROM THIS BOX HAVE NO MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317088 ↗
• MalfunctionJul 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING A BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G X 1 1/2 IN., LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE DILUENT WAS INJECTED INTO THE VIAL, THE LUERLOCK OF THE SYRINGE STARTED SPRAYING DILUENT AND AN UNKNOWN AMOUNT OF DILUENT WENT INTO THE VACCINE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136552 ↗
• MalfunctionJul 21, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED VIA PHONE CALL ON (B)(6) 2022. CUSTOMER STATES THAT LEAKAGE/SPRAYING FROM LUER LOCK. DOE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080703 ↗
• MalfunctionApr 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICLE CONTAMINANT ON STERILE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120458 ↗
• MalfunctionMar 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING A BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G X 1 1/2 IN. THIN WALL, STERILE, SINGLE USE, 3 ML, LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED CALL FROM CUSTOMER STATING THAT WHEN GIVING DEPO SHOT THE MEDICATION LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739129 ↗
• MalfunctionSep 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 23X1-1/2 RB TW EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINANT ON STERILE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471530 ↗
• MalfunctionJun 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 23X1-1/2 RB TW EXPERIENCED LIQUID/MOISTURE/DROPLETS IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309589, BATCH NO: 0317557, 0308897. IT WAS REPORTED FM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071709 ↗
• MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 23X1-1/2 RB TW EXPERIENCED LIQUID/MOISTURE/DROPLETS IN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309589, BATCH NO: 0308898. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040515 ↗
• MalfunctionJan 29, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE, A BD¿ LUER-LOK SYRINGE PRECISIONGLIDE NEEDLE WAS FOUND LEAKING AS CONSUMER REPORTED THEY WERE ¿GIVING A SHOT OF B12, AND THE MEDICATION LEAKED OUTSIDE OF THE SYRINGE AND ONTO THE FLOOR.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7224694 ↗

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-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-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-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-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-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