Class II — Potential Health Hazard

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

XVIVO Organ Chamber REF 19020 Recalled by XVIVO PERFUSION AB Due to The weld seal of the primary pouch was...

Date: April 8, 2022
Company: XVIVO PERFUSION AB
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 XVIVO PERFUSION AB directly.

Affected Products

XVIVO Organ Chamber REF 19020

Quantity: 80 devices

Why Was This Recalled?

The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Where Was This Sold?

This product was distributed to 8 states: CA, FL, MA, NY, NC, OH, PA, TX

Affected (8 states)Not affected

About XVIVO PERFUSION AB

XVIVO PERFUSION AB has 1 total recall tracked by RecallDetector.

Related Recalls

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