V. Mueller SU16005Recalls & reported problems

Steris Corporation · V. Mueller VITAL CRILE-WOOD NEEDLE HOLDER STRAIGHT, SERRATED INSERTS OVERALL LENGTH 6 inches 15.2CM · Class 1

All models of V. Mueller (118)

Data updated Oct 16, 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 10885403061912), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Detachment of Device or Device Component1

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.

MalfunctionJan 16, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TIP OF THEIR VITAL CRILE NEEDLE WOOD HOLDER DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095273 ↗

Device details

UDI-DI	`10885403061912`
Brand	V. Mueller
Model	SU16005
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 21, 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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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