Henry Schein 5700735Recalls & reported problems

Henry Schein, Inc. · 25G Safety Butterfly Blood Collection Needle · Class 2

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 10304040063641), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Fluid/Blood Leak1

Patient problems

Intraoperative Cardiac Valve Injury1

Recent adverse event reports

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

MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED: THE CUSTOMER ADVISED THAT THE BLOOD WOULD SPILL OUT. THE CUSTOMER DISPOSED OF THE DEFECTIVE ITEM.
Patient problems: Intraoperative Cardiac Valve Injury
MAUDE report 22035475 ↗

Device details

UDI-DI	`10304040063641`
Brand	Henry Schein
Model	5700735
Company	Henry Schein, Inc.
Product code	JKA · Tubes, vials, systems, serum separators, blood collection
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	Jul 23, 2020

Device type (GMDN): Venous butterfly needle/set

An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.

Other Tubes, vials, systems, serum separators, blood collection devices

BD Vacutainer® SST™ 367986
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
2 recalls2,711 reports
BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
1 recall1,744 reports
BD Vacutainer® SST™ II Advance 367955
Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection
1,478 reports
BD Vacutainer® Eclipse™ Blood Collection Needle 368607
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
1,220 reports
BD Vacutainer® SST™ 367983
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
2 recalls1,075 reports
BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
1,010 reports
BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
1 recall747 reports
BD Vacutainer® SST™ II Advance 367957
Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection
767 reports

All Tubes, vials, systems, serum separators, blood collection 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.

How reports and recalls are matched · Editorial policy · Report an error on this page