---
title: "XVIVO Organ Chamber REF 19020 — FDA record Z-1212-2022 | Is It on Recall"
description: "The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed."
url: https://isitonrecall.com/recall/fda-device-z-1212-2022-xvivo-organ-chamber-ref-19020/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# XVIVO Organ Chamber REF 19020 — FDA record Z-1212-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: XVIVO Organ Chamber REF 19020
- **Reason**: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
- **Classification**: Class II
- **Recalling firm**: XVIVO PERFUSION AB
- **Quantity**: 80 devices
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1212-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1212-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jun 8, 2022
- **Recall initiation date**: Apr 8, 2022
- **Center classification date**: Jun 1, 2022
- **Termination date**: Jan 30, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1212-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [XVIVO PERFUSION AB records](https://isitonrecall.com/brand/xvivo-perfusion-ab/)