Henry Schein 9007647Recalls & reported problems

Henry Schein, Inc. · Syringe/Needle Combo Safety3cc · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040017128), received between Jun 17, 2025 and Jun 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

May 9, 2024Open, Classified
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Z-3074-2024 · Root cause: Other · FDA record ↗

Most reported problems

Device problems

Dull, Blunt1

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.

MalfunctionJun 17, 2025Dull, Blunt; Dull, Blunt
THE CUSTOMER ADVISED THAT THESE SYRINGES DO NOT EXPIRE UNTIL 2026, HOWEVER THE NEEDLES ARE DULL AND ARE NOT WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22226574 ↗

Device details

UDI-DI	`00304040017128`
Brand	Henry Schein
Model	9007647
Company	Henry Schein, Inc.
Product code	FMF · Syringe, piston
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 12, 2018

Device type (GMDN): General-purpose syringe, single-use

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.