Class II — Potential Health Hazard

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

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Recalled by Abbott Due to As a result of a manufacturing error, one...

Date: November 16, 2021
Company: Abbott
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 Abbott directly.

Affected Products

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

Quantity: 10 units

Why Was This Recalled?

As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott

Abbott has 19 total recalls tracked by RecallDetector.

Related Recalls

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