Class II — Potential Health Hazard

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

DREAMTOME 44-30MM/450CM Material Number: M00584070 Recalled by Boston Scientific Corporation Due to Sterility of device is compromised due to a...

Date: December 22, 2021
Company: Boston Scientific Corporation
Status: Ongoing
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 Boston Scientific Corporation directly.

Affected Products

DREAMTOME 44-30MM/450CM Material Number: M00584070

Quantity: 142 units

Why Was This Recalled?

Sterility of device is compromised due to a sterile barrier breach

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

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