Which infamous medical device recall in the 1980s led to major reforms in the FDA's medical product recall system and introduced the requirement for unique device identification?

In the medical industry, product recalls can have life-or-death consequences. The FDA's recall classification system and protocols have evolved significantly over the decades to protect patients. This trivia question explores a pivotal moment in medical product recall history that fundamentally changed how medical device manufacturers address safety concerns and implement recall procedures. Test your knowledge about this critical aspect of healthcare product management and patient safety.

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Björk-Shiley heart valve failures (1986)
Dalkon Shield intrauterine device (1984)
Baxter dialysis filters contamination (1989)
Synthes bone cement misuse (1983)