On 29 September 2025, the FDA announced that the pilot program for rapid medical device recall communications (the ‘Early Alerts system’ for device recalls) was being expanded.
Medical Device Recalls: Early Alert System
The FDA’s Early Alert System for medical device recalls was designed to minimise delays between FDA awareness and communication of recalls to health care providers and the public. This pilot ‘early alerts’ communications program for medical device recalls was launched in November 2024.
On 29 September 2025, the FDA announced the expansion of this pilot program.
Here’s what manufacturers and distributors of medical devices need to know about recall readiness and the FDA’s early alerts system for communication of medical device recalls.
History of Early Alert Pilot for Medical Device Recalls
Referred to as the Early Alert Pilot, this rapid communications program for medical device recalls “was developed as part of CDRH’s efforts to enhance medical device recall programs”, referring to the CDRH’s 2024 Safety Report/recommendations. Its origins included input from an earlier (2021) Patient Engagement Advisory Committee (PEAC) meeting about high-risk medical devices, and the need for an improved communications system to protect public health/patient safety. Source: Adapted from FDA notification about pilot communications for medical device recalls.
- PILOT SCOPE (1st Year of the Pilot): This early recall alert system initially focused on select medical device categories (cardiovascular, gastrorenal, general hospital, OB/GYN, and urology).
- SCOPE EXPANSION: On 29 September 2025, the FDA announced the Early Alert Pilot was being expanded to include early communication of recall information for all types of medical devices where there is potential patient risk, not just the categories listed in the pilot system when it was first implemented.
- OVERVIEW: The FDA notes this change has broadened the pilot’s scope, enhances transparency about medical device defects/quality issues, and strengthens patient safety across the full range of medical devices.
Critical timing, early recall alerts and a well-prepared team
When it comes to medical device recalls, timing is critical — both for patient safety and for ensuring the recall runs smoothly. That’s why recall readiness training is so important.
GMP regulations and other standards require the following types of recall training for personnel:
- Site-specific recall training (plus adequate resources and Supervision for the recall team)
- Product specific recall training (for example, recalls of implanted medical devices, recalls of pharmaceuticals or combination devices)
- Data Integrity training, Good Warehouse Practice & Good Distribution Practice training
- GMP compliance & Recall training requirements
Best practice recall training & preparation (e.g., mock recalls)
How well you prepare your teams to conduct efficient & effective pharmaceutical recalls and/or medical device recalls, is something auditors tend to examine during an inspection/GMP audit.
Preparing your team should be an ongoing exercise. Even running mock recalls (practice drills) is considered a best-practice step to make sure everyone knows what to do, when it matters most to healthcare outcomes/patient safety.
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Importance of Recall Training for medicines & devices.
Recall training strategies are more than simply meeting regulatory compliance requirements for recall training. This training is an essential step for patient safety, product integrity, brand reputation, and business sustainability
Primary aim of Communications Pilot Program (Early Alert System)
The FDA’s Center for Devices and Radiological Health (CDRH) launched the Communications Pilot Program in November 2024. Announced by Dr. Michelle Tarver, Director of CDRH, the primary aim of the pilot program (including its recent expansion) is to minimise the delay between the FDA’s initial awareness of a device issue and its public communication.
Complying with the ‘Early Alert System’ communications pilot program improves the timeliness of public notifications about recalls of high-risk medical devices recalls.
This Early Alert System also focuses on corrective actions such as:
- Product removals from the market
- Updates to usage instructions
- Safety-related corrections
FAQ: Which areas of healthcare/medical devices did the Pilot involve before it was expanded?
The pilot Early Alert System initially focused on high-risk products such as:
- Cardiovascular devices
- Gastrorenal devices
- General hospital devices
- Obstetrics and gynecology devices
- Urology devices
Speedy communications regarding medical device recalls are critical for patient safety. The expansion of the FDA’s Early Warning System (pilot) to include recall information across all medical device types, in addition to high-risk categories categories already included in the program, will improve transparency about product defects and quality issues. Ultimately, it will help protect patients, and for products that are found to have serious defects, it will save lives.
How Can Industry Stay Prepared for a Medicine or Medical Device Recall?
The FDA continues to improve its communication systems to alert the public, surgeons, GPs and other healthcare providers about medical device recalls.
This means manufacturers, sponsors, and distributors must also ensure their internal recall procedures are robust, compliant, and responsive.
That’s where Online GMP Training comes in.
🎓 Recalls of Therapeutic Goods – Online Course
This GMP eLearning course covers Regulatory Compliance requirements relating to recall preparations, including personnel recall training, recall reconciliation/product reconciliations, and documentation requirements. It is designed for a global audience including medical device manufacturing personnel and pharmaceutical manufacturing teams.
PharmOut’s Recall training for regulated sectors will benefit all levels of professionals working with pharmaceuticals, medical devices, and other therapeutic goods. Designed for a global audience and applicable to all types of medicinal devices and pharmaceutical products, this course is an excellent addition to site-specific and product-specific recall training.
This site offers Certificate GMP training courses for regulated industries. The Recalls Training course is a certificate course designed to help your personnel understand the requirements for planning and implementing a product recall, including the importance of batch records and distribution records.
Complete the GMP Industry Recalls Training Course for Recalls of Medicines & Medical Devices.
- Regulatory frameworks for planning and implementing recalls (PIC/S, FDA, TGA, EMA, MHRA)
- Best practices for recall execution and documentation
- Training requirements in recall readiness for personnel (medicine & medical device recall training)
- Importance of mock recall exercises and internal communication strategies for medicine and medical device recalls
- Other requirements for product recall policies and SOPs and integration into the PQS/QMS
Last updated on October 1st, 2025 at 06:53 pm
