# FDA recall Z-0029-2020

> **CooperSurgical, Inc.** · Class III · device recall initiated 2019-09-05.

## Product

Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

## Reason for recall

The touchpad may not work properly after cleaning.

## Distribution

Worldwide distribution - including US Nationwide in the states of CA, CO, CT, GA, IL, MI, NC, NJ,  PA, & WA, and countries of Canada and Denmark.

## Key facts

- **Recall number:** Z-0029-2020
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-05
- **Report date:** 2019-10-09
- **Termination date:** 2021-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2020

## Citation

> AI Analytics. FDA recall Z-0029-2020. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0029-2020. Source: US FDA. Licensed CC0.

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