Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
Category: Standards
Standards
Latest
Standards
Latest
New Hospital Visitor System Features ‘Always-On’ Offline Capability
Managed from an Apple iPad, the system is designed to maintain visitor check-in, logging, and badge printing functions even during internet or power outages.
Court Upholds DMCA Repair Exemption for Medical Devices
A US District Court has upheld a rule allowing limited circumvention of copyright protections for the repair and maintenance of medical devices.
Read More
Strengthening Industry-Government Relationships Amid Leadership Transitions
Advocacy built on long-term relationships can help HTM professionals stay influential as agency leaders and lawmakers change.
Read More
Playbook for Managing Connected Medical Devices
A seven-step guide to managing and securing connected medical devices across healthcare delivery organizations.
Read More
Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks
A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.Â
Read More
FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
Read More
BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
Read More
SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
Read More
BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues
Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.
Read More
Senate NDAA Includes Right-to-Repair Provision for Military Equipment
Advocacy groups urge the House to adopt similar language in its version of the bill.
Read More
Lake Havasu City Physical Therapist Dies in Hyperbaric Chamber Fire
Walter Foxcroft III was killed in a flash fire inside a hyperbaric chamber, according to the Lake Havasu City Fire Department. Foxcroft was the founder of Havasu Health and Hyperbarics, where the incident occurred.
Read More
Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits
AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.
Read More
Bipartisan Bill Would Expand Military’s Right to Repair Equipment
The newly introduced legislation would require all military branches to include right to repair provisions in contracts, aiming to cut costs and improve readiness.
Read More