Henry Schein 5702703Recalls & reported problems
Henry Schein, Inc. · Needle Disposable Safety 25Gx1 · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10304040154172), received between May 16, 2025 and Feb 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 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.
Reports received per month
Most reported problems
Device problems
- Defective Component2
- Complete Blockage1
- Device Contamination with Chemical or Other Material1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions1
- Skin Discoloration1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Defective Component
CUSTOMER REPORTS THAT THEY HAD A RECENT NEEDLESTICK INJURY. THEY ARE UNABLE TO DETERMINE WHICH OF THESE LOTS CAUSED THE NEEDLESTICK INJURY AS THESE LOTS WERE IN THE BIN THE NEEDLE WAS STOCKED IN AND THE PACKAGING WAS NOT SAVED WHEN IT WAS BEING USED.
Patient problems: Needle Stick/Puncture
MAUDE report 24398998 ↗MalfunctionNov 7, 2025Complete Blockage; Complete Blockage
CUSTOMER REPORTED:"ON 10/09/2025 (B)(6) DISCOVERED ON THE FDA MAUDE DATABASE A VOLUNTARY REPORT FILED UNDER MW5176404. PER THE REPORT "PATIENT PRESENTED FOR AN INFLUENZA VACCINE. NEEDLE (B)(6) SAFETY NEEDLE 25G 1) WAS CORRECTLY PLACED ONTO INFLUENZA VACCINE SYRINGE, MAINTAINING STERILE TECHNIQUE. PATIENT'S SKIN WAS PREPPED WITH ISOPROPYL ALCOHOL SWAB. NEEDLE (ATTACHED TO INFLUENZA VACCINE SYRINGE) WAS INSERTED INTO PATIENT'S SKIN, BUT PLUNGER WOULD NOT MOVE. NEEDLE (ATTACHED TO INFLUENZA VACCINE SYRINGE) WAS THEN WITHDRAWN, AND NEEDLE WAS REPLACED WITH A NEW NEEDLE. (B)(6) SAFETY NEEDLE 25G) MAINTAINING STERILE TECHNIQUE. PATIENT'S SKIN WAS AGAIN PREPPED WITH ISOPROPYL ALCOHOL SWAB. AFTER THAT, NEW NEEDLE (ATTACHED TO INFLUENZA VACCINE SYRINGE) WAS INSERTED INTO PATIENT'S SKIN, AND PLUNGER OF SYRINGE WORKED AS INTENDED. INFLUENZA VACCINE WAS THEN SUCCESSFULLY ADMINISTERED TO PATIENT. PATIENT TOLERATED PROCEDURE WELL". THE PATIENT WAS A 15 YEAR OLD, SEX OF PATIENT UNKNOWN, PATIENT ETHNICITY IS NON HISPANIC, AND PATIENT RACE IS WHITE. THE END USER OF THIS PRODUCT IS UNKNOWN AND REASON IT IS NOT POPULATED ON THIS EVENT REPORT, WE DOCUMENTED THIS UNDER (B)(6) INSTEAD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495086 ↗MalfunctionJun 24, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THEY HAD TWO NEEDLESTICK INJURIES.
Patient problems: Needle Stick/Puncture
MAUDE report 22318541 ↗MalfunctionMay 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CUSTOMER REPORTED A GREY DISCOLORATION WAS LEFT AT THE INJECTION SITE WHEN USED.
Patient problems: Skin Discoloration
MAUDE report 22035776 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.