Class II — Potential Health Hazard

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

One Step Button Recalled by Boston Scientific Corp Due to Boston Scientific Corp. initiated a voluntary recall of...

Date: September 11, 2015
Company: Boston Scientific Corp
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 Boston Scientific Corp directly.

Affected Products

One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

Quantity: 22 units

Why Was This Recalled?

Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

Where Was This Sold?

This product was distributed to 9 states: CA, CT, IN, NV, NY, PA, TN, WA, WI

Affected (9 states)Not affected

About Boston Scientific Corp

Boston Scientific Corp has 7 total recalls tracked by RecallDetector.

Related Recalls

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