Henry Schein 5701403Recalls & reported problems

Henry Schein, Inc. · Dental syringe, 6cc Luer Lock Non sterile · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10304040108786), received between Jul 20, 2024 and Jul 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER ADVISED THAT THE SYRINGE CAME APART AT THE SEAM, AND THE CONTENTS SPILLED ON THEIR CLOTHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19786338 ↗

Device details

UDI-DI	`10304040108786`
Brand	Henry Schein
Model	5701403
Company	Henry Schein, Inc.
Product code	EIC · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 5, 2019

Device type (GMDN): Anaesthesia Luer syringe, non-sterile

A non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer (infuse) anaesthetic drugs. At the distal end of the barrel is a male Luer connector (typically a Luer-lock type) for the attachment of the female connector (hub) of a hypodermic needle, administration set or dental syringe cannula. It is typically made of plastic and silicone materials and may have anti-stick properties (internally precoated with compatible substances) that allow the plunger to move smoothly. This is a single-use device.

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All SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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