V. Mueller SU16062Recalls & reported problems

Steris Corporation · V. Mueller VITAL MAYO-HEGAR NEEDLE HOLDER, TUNG CARB INSERTS 2500 TEETH PER SQUARE INCH OVERALL LENGTH 8 inches 20.3CM · Class 1

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 10885403002465), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Break1

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 25, 2025Break; Break
THE USER FACILITY REPORTED WHILE USING THEIR DORSEY FENESTRATED GRASPER DURING PATIENT PROCEDURES THAT A SCREW FELL INTO THE SURGICAL FIELD. NO REPORT OF INJURY OR PROCEDURE DELAYTHE USER FACILITY REPORTED THAT THREE OF THEIR MAYO HEGAR NEEDLE HOLDERS HAVE CAUSED SUTURE NEEDLES TO BREAK. THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22612575 ↗

Device details

UDI-DI	`10885403002465`
Brand	V. Mueller
Model	SU16062
Company	Steris Corporation
Product code	MDM · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 15, 2024

Device type (GMDN): Suturing needle holder, reusable

A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable 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.