Severity
Low
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
Reported: October 9, 2019 Initiated: September 5, 2019 #Z-0029-2020 60 units
CooperSurgical, Inc. issued this FDA Devices recall on October 9, 2019. Classified as Low severity (Class III). Approximately 60 units are affected. The recall was issued because: The touchpad may not work properly after cleaning.. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0029-2020) was formally reported on October 9, 2019, with the manufacturer initiating the action on September 5, 2019. It is classified under Low severity (Class III), with a current status of Terminated. CooperSurgical, Inc. is listed as the recalling firm, operating out of Trumbull, CT. Federal records indicate 60 units are affected.
The documented reason for this recall is: The touchpad may not work properly after cleaning. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
60
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
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.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 60
- 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.
- Location
- Trumbull, CT
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0029-2020 |
| Date reported | October 9, 2019 |
| Date initiated | September 5, 2019 |
| Recalling firm | CooperSurgical, Inc. |
| Units affected | 60 |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CooperSurgical, Inc.. Units affected: 60.
Why was this product recalled? ▼
The touchpad may not work properly after cleaning.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Low. Recall number: Z-0029-2020.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0029-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).