Henry Schein 5700734Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10304040063634), received between May 16, 2025 and Jun 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTED THAT THE NEEDLE IS SLIDING OFF AND WONT STAY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22226603 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  THE CUSTOMER REPORTS THAT THE SAFETY MECHANISM MALFUNCTIONED CAUSING A NEEDLESTICK INJURY. AS OF NOW, NO UDI#. A 62 YEAR OLD FEMALE WAS PERFORMING A HAND DRAW PROCEDURE WHEN THEY HAD RECEIVED A NEEDLESTICK INJURY. IT WAS A DIRTY STICK AS PATIENT HAD BEEN DRAWN. THE SITE AREA IS WASHED AND FOLLOWED UP WITH THE ER. FOLLOW SERIAL BLOOD DRAWS AT 6 WEEKS, 3 MONTHS, 6 MONTHS POST EXPOSURE. LNI FILED. ALL FOLLOW UP THROUGH OCCUPATIONAL HEALTH CLINICS. ONLY ONE REPORTED DEVICE INJURY AT THIS CLINIC FOR THIS DEVICE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035791 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER THE CUSTOMER REPORTS THAT THE SAFETY MECHANISM MALFUNCTIONED CAUSING A NEEDLESTICK INJURY. AS OF NOW, NO UDI#. A 29 YEAR OLD FEMALE WAS PERFORMING A RIGHT AC PROCEDURE. GLOVES WERE BEING WORN AT THE TIME. IT WAS A DIRTY NEEDLESTICK AS PATIENT HAD BEEN DRAWN. THE SITE OF THE NEEDLESTICK WAS WASHED AND FOLLOWED UP WITH THE ER. FOLLOW SERIAL BLOOD DRAWS AT 6 WEEKS, 3 MONTHS, 6 MONTHS POST EXPOSURE. LNI FILED. ALL FOLLOW UP THROUGH OCCUPATIONAL HEALTH CLINICS. ONLY ONE REPORTED DEVICE INJURY AT THIS CLINIC FOR THIS DEVICE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035758 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  THE CUSTOMER REPORTS THAT THE SAFETY MECHANISM MALFUNCTIONED CAUSING A NEEDLESTICK INJURY. AS OF NOW, NO UDI#. A 37 YEAR OLD FEMALE WAS PERFORMING A RIGHT HAND PROCEDURE WHEN THEY HAD RECEIVED A NEEDLESTICK INJURY. IT WAS A DIRTY STICK. THE SITE AREA WAS WASHED AND FOLLOWED UP WITH THE ER. FOLLOW SERIAL BLOOD DRAWS AT 6 WEEKS, 3 MONTHS, 6 MONTHS POST EXPOSURE. LNI FILED. ALL FOLLOW UP THROUGH (B)(6). ONLY ONE REPORTED DEVICE INJURY AT THIS CLINIC FOR THIS DEVICE. GLOVES WERE BEING WORN AT THE TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035754 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "CUSTOMER REPORTED THE PLASTIC PROTECTIVE CASING AROUND THE NEEDLES EASILY SLIDE OFF WITHOUT HAVING TO TOUCH THEM. THE SAFETY LOCKING MECHANISM IS OFTEN LOOSE AND CLOSES UPON ITSELF WHILE THE NEEDLE IS INSIDE THE PATIENT'S ARM. SOME NEEDLES HAVE HAD MISSING ATTACHMENTS LIKE CONNECTORS. NEEDLE HOLDER ATTACHMENT DETACHED WHILE CHANGING TUBES. IT SEEMS TO BE MORE PAINFUL FOR THE PATIENTS."

  Patient problems: Pain

  MAUDE report 22035524 ↗