Effectively Manage Medical Device Recalls, Field Actions, and Alerts
Software defects and sterility issues remain among the leading causes of medical device recalls, field actions, and alerts. Class I recalls — the FDA’s highest-risk designation — carry significant regulatory exposure when supply chain notification isn’t fully documented.
TRIEVR Recall is an on-demand SaaS platform that replaces manual, error-prone notification and tracking with a documented, auditable workflow — including FDA reporting tools to help your team compile and submit required regulatory information.
Manual Recall Processes Create Regulatory and Legal Exposure
Phone trees, spreadsheets, and email chains are not an audit trail. When the FDA reviews your recall execution, they will examine every communication, every timestamp, and every non-response.
TRIEVR replaces ad hoc manual processes with a structured, documented workflow purpose-built for regulatory defensibility — at a fraction of the cost of legacy QMS platforms. Our SaaS platform can have your recall underway in minutes.
Enterprise-Grade Recall Execution
Platform Features Purpose-built for medical device recall operations in regulated markets.
to all stakeholders
with its corresponding communications
tracks and monitors where all recalls are in the process and who has yet to respond
large amounts of data from multiple sources
Progress Dashboard
Additional Capabilities for End-to-End Recall Execution Beyond core workflow automation, TRIEVR supports the operational details recall execution requires — from stakeholder response handling to product retrieval logistics.
Our platform also Includes:
+ Additional Options
ON-DEMAND SUPPLY CHAIN CALL CENTER
Includes scripts, training, inbound and outbound international calls through our partner IRC.
consumer toll free hotline
Consumer toll free number hotline
custom return kits
Custom return kits based on customer specs
No Response Post Cards
Includes logo, unique tracking IT, and QR code with instructions
first response post cards
For those with no email address available
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What Customers Are Saying
“Set up was easy, and loved the e-signature capability”
“Because of their templates, I was able to get our recall initiated within 30 minutes.”