GAO Report: FDA Falling Short Regarding Medical Device Recalls
February 8, 2026
The United States Government Accountability Office (GAO) issued a report to the United States Congress in December 2025 entitled “HHS and FDA Should Address Limitations in Oversight of Recall Process” in which it stated: From fiscal years 2020 to 2024, FDA oversaw the recall of 3,934 med[...]
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Stryker Defibrillator Recall
March 3, 2019
On February 1, 2019, Stryker issued an “URGENT MEDICAL DEVICE SAFETY NOTICE & CORRECTION ACTION REQUIRED” regarding its LIFEPAK® 15 Monitor/Defibrillator, stating that “Stryker is conducting a voluntary Field Action for specific LIFEPAK 15 Monitor/Defibrillator devices that m[...]
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When Did Hip Replacement Manufacturer Know About Failures?
March 5, 2012
In an article appearing in The New York Times on February 21, 2012, it was reported that the all-metal artificial hip replacement known as the DePuy ASR (articular surface replacement) manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, which was implanted in 93,000 pati[...]
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