Medical Device Recalls and Early Alerts | FDA
Oct 10, 2025 · The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues.
15+ device recalls in 2025 - Becker’s ASC
Nov 17, 2025 · Here are 17 medical device and technology recalls, as reported by Becker’s so far in 2025: Note: This list is not exhaustive. Abiomed issued a recall alert after identifying a cybersecurity …
Recall Roundup: FDA medical device recalls in July 2025
Aug 4, 2025 · If so, welcome to Recall Roundup, where we keep our eyes on the FDA’s recent medical device recalls. First, a company takes action, then the FDA categorizes that action as a recall from …
Pilot program was initiated in Nov. 2024 – limited to Class I recalls involving cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices
The Therapeutic Goods Administration (TGA) implemented major reforms to Australia’s regulations related to software-based medical devices, including software that functions as a medical device.
Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven ...
Sep 4, 2025 · Medical device recalls reached their highest quarterly total for Class I events in 20 years during Q2 2025, with 36 recalls impacting 4.29 million units, according to Sedgwick’s newly released …
Medical Device Recalls News | MedTech Dive
Dec 2, 2025 · While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death. After a successful pilot, the agency has lifted the …
Medical Device Recall Statistics: 2025 Data – XS Supply
Nov 12, 2025 · First quarter 2025 data indicate continued elevated recall activity despite slight decreases in total events. Healthcare procurement teams must prepare for ongoing supply chain …
FDA Recalled 4 Pharma, 2 Medical Products in Q2 2025
Jul 3, 2025 · Four pharmaceutical recalls related to microbial contamination, polypropylene particulates, and mispackaging. They are labeled CDER, for FDA’s Center for Drug Evaluation and Research.
The FDA rarely forces manufacturers to recall dangerous medical devices ...
Dec 16, 2025 · The FDA has received more than 500 reports of deaths associated with the devices since 2021, according to the agency’s last update. Dr. Rita Redberg, a cardiologist and expert on …