Never Miss an FDA Medical Device Recall
57,000+ FDA recall records and 38,000+ enforcement actions, filtered by your device profile. Each signal scored with reasons for your RA/QA team to review.
Last updated: February 2026
Why Monitor FDA Recalls for Your Device?
Regulatory Compliance
FDA and EU MDR require manufacturers to monitor recalls for similar devices as part of post-market surveillance obligations.
Risk Management
Recalls affecting similar devices may signal risks relevant to your product. ISO 14971 requires documenting these signals.
Competitor Intelligence
Track competitor device recalls to understand market dynamics and identify potential gaps in your own quality systems.
Inspection Readiness
When inspectors ask what recalls you monitored and how you responded, your evidence pack has the answers ready.
How Recall Monitoring Works
Set up your device profile
Enter your device name, keywords, and product codes. We filter all recall and enforcement records to match your device.
Review scored signals
Each recall is scored HIGH, MID, or LOW based on relevance to your device. Reasons and suggested actions are provided for each.
Approve or override
Your RA/QA team reviews each signal. Approve & save the scoring, or override with your own judgment and reasoning.
Export evidence
Export reviewed recalls as inspection-ready CSV with audit trail. Coverage statements available on Pro plans.
Start monitoring FDA recalls for your device
Free account. Set up in under 2 minutes. No credit card required.
Frequently Asked Questions
How do I monitor FDA medical device recalls?
FDA medical device recalls can be monitored through the FDA Enforcement Reports API (api.fda.gov/device/enforcement), the FDA Recalls database (api.fda.gov/device/recall), and the FDA Safety Communications page. These cover Class I, II, and III recalls, corrections, and removals.
What is the difference between FDA recall classes?
Class I recalls involve situations where there is a reasonable probability of serious adverse health consequences or death. Class II recalls may cause temporary or medically reversible adverse health consequences. Class III recalls are not likely to cause adverse health consequences but violate FDA regulations.
How quickly must I report a recall to FDA?
Under 21 CFR 806.10, manufacturers and importers must submit a written report to FDA within 10 working days of initiating any correction or removal to reduce a risk to health or to remedy an FD&C Act violation.
Does a US recall trigger Health Canada obligations?
Yes. Under Health Canada SOR/2024-133, Section 61.2, if a foreign regulatory authority (like the FDA) communicates a serious risk of injury to health related to your device, you must report that to Health Canada. This cross-jurisdiction trigger is frequently overlooked.
What records should I keep for recall monitoring?
Maintain records of all monitored recall signals, your assessment of relevance to your device, the decision rationale, any actions taken, and traceability back to the original FDA source. Under 21 CFR 806.20, even corrections/removals NOT reported to FDA require documented records.
Also see: PMS Monitoring Tool · FDA 510(k) Database · Try Free Demo