Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

U-SDN 2 Part Ultra Modified Seldinger Needles Recalled by Procedure Products, Inc. Due to The firm had received a complaint alleging that...

Date: October 27, 2015
Company: Procedure Products, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Procedure Products, Inc. directly.

Affected Products

U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.

Quantity: 1100 pieces

Why Was This Recalled?

The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle

Where Was This Sold?

This product was distributed to 2 states: MT, NY

Affected (2 states)Not affected

About Procedure Products, Inc.

Procedure Products, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report