N/A 309624Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903096245), received between Apr 13, 2018 and Jul 9, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19706873 ↗
• MalfunctionOct 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 1ML S/T W/NDL 21X1 RB NEEDLE PULLED OUT OF THE HUB BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED HE CURRENTLY USES THE 1 ML TUBERCULIN SYRINGE AND WHEN REMOVING THE NEEDLE CAP THE NEEDLE COMES OFF WITH IT. STATED THE NEEDLE CAP SEEMS TO BE ON ULTRA TIGHT AND THE NEEDLE IS "SNUG" BUT NOT ON TIGHT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659744 ↗
• MalfunctionApr 13, 2018Device Packaging Compromised

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PACKAGE OF BD TUBERCULIN SYRINGE(S) W/ PRECISION GLIDE¿ NEEDLE(S) THAT WERE PACKAGED DEFECTIVELY, SUCH THAT THE STERILE BARRIER WAS COMPROMISED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430366 ↗

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-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-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-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