Class II — Potential Health Hazard

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

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 Recalled by Signal Medical Corporation Due to Foreign Object Contamination

Date: February 20, 2017
Company: Signal Medical 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 Signal Medical Corporation directly.

Affected Products

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Quantity: 1,640

Why Was This Recalled?

Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Signal Medical Corporation

Signal Medical Corporation has 3 total recalls tracked by RecallDetector.

Related Recalls

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