CooperSurgical Embryology Heated Plate Recall Due to Touchpad Malfunction
CooperSurgical is recalling 60 Embryology Heated Plates within the RI Witness system because the touchpad may not work properly after cleaning.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor functional issues.
Plain-English summary
CooperSurgical, Inc. is recalling 60 units of the Embryology Heated Plate within the RI Witness system, Model Numbers 6-70-807, 6-70-807-A, and 6-70-807-B. The recall is due to a defect where the touchpad may not work properly after cleaning.
The affected products were distributed worldwide, including in the United States (CA, CO, CT, GA, IL, MI, NC, NJ, PA, and WA) and in Canada and Denmark. The RI Witness system uses Radio Frequency Identification (RFID) to detect and monitor activity in IVF laboratories to mitigate human error and safeguard the IVF cycle.
The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences. CooperSurgical, Inc. is the recalling firm responsible for addressing the issue.
The recalled product
- 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…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 60
Distribution
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