Class II — Potential Health Hazard

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

TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Recalled by Boston Scientific Corporation Due to Sterility of device may be compromised due to...

Date: November 20, 2013
Company: Boston Scientific Corporation
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 Corporation directly.

Affected Products

TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

Quantity: 425 eaches

Why Was This Recalled?

Sterility of device may be compromised due to lack of pouch seal integrity

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