I have seen very few products that are being recalled very early. I think the products that are recalled very early shows how much company are concerned regarding the safety. One I would like to discuss is ATAR Reusable and Disposable Extension Cable(s) by OSCAR.
Reason for recall was risk of the extension cables separating from the connectors during use. Which could lead to failure of cardiac pacing therapy for the patient. As the failure occurs without warning, it is possible that pacing-dependent patients may suddenly be left unpaced without adequate warning to their caregivers to quickly exchange the defective cable. Sudden pacing delay and/or failure may result in immediate and serious condition.

Comapany sold 13000+ cables and only 66 of them were reported for the recall. I think this recall was way to early. But I would like to know how to decide and probably what time to decide that product was eligible for a recall?

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm568011.htm