Class II — Potential Health Hazard

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

Custom Breast Biopsy Tray w/Sodium Chloride Recalled by Custom Healthcare Systems, Inc. Due to Surgical procedure trays are packed with pharmaceuticals for...

Date: November 26, 2012
Company: Custom Healthcare Systems, Inc.
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 Custom Healthcare Systems, Inc. directly.

Affected Products

Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

Quantity: 80 trays

Why Was This Recalled?

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Custom Healthcare Systems, Inc.

Custom Healthcare Systems, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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