Recall & FSCA Toolkit
FDA recall strategy, recall notification package, customer letters, EU MDR FSCA/FSN package, effectiveness check protocol, and recall termination templates — for when a recall cannot wait.
What You Get
Recall Strategy and Risk Assessment Template (FDA 21 CFR Part 7)
Structured recall strategy template for FDA Class I, II, and III medical device recalls. Covers recall classification determination, depth of recall (consumer, retail, wholesale, sub-wholesale), recall strategy elements, public warning determination, and the recall strategy effectiveness check design. Structured per FDA 21 CFR Part 7 and the Medical Device Recall Database requirements.
Recall Initiation and FDA Notification Package Template
Complete recall notification package for initial FDA reporting. Covers the 10-day reporting requirement, recall notification letter to district office, recall-related product information (device description, lot/serial identification, distribution records), reason for recall statement, and the recall strategy summary that FDA evaluates to determine whether the recall strategy is adequate.
Customer Recall Notification Letter Template
Customer-facing recall notification letter template aligned with FDA guidance on recall communications. Covers required elements: device identification, reason for recall, action customers should take, health hazard description appropriate for audience, and return/disposal instructions. Includes versions for healthcare professional audiences and distributor notification letters.
EU MDR Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) Package
Complete FSCA/FSN package for EU MDR Article 89 obligations. Covers FSCA scope determination, FSN content requirements per MDCG 2023-3, competent authority notification timelines (15-day initial report), authorized representative coordination, EUDAMED FSCA report requirements, and the follow-up periodic update reporting obligations that apply until FSCA is closed.
Recall Effectiveness Check Protocol Template
Structured effectiveness check protocol for verifying recall completeness. Covers effectiveness check methodology (audit, survey, sample verification), sample size determination, check frequency by recall class, and the effectiveness check documentation that FDA reviews to confirm the recall is achieving its intended purpose. Includes the criteria FDA uses to determine recall termination readiness.
Recall Termination Request Package Template
Documentation package for formal recall termination with FDA. Covers the effectiveness check data compilation, lot/serial accountability report, distribution list reconciliation, and the recall termination letter format FDA expects. Includes the FSCA closure documentation for EU MDR with competent authority notification and EUDAMED update requirements.
FAQ
When must a medical device recall be reported to FDA?
Manufacturers must report recalls to FDA within 10 working days of initiating a recall. The report goes to the applicable FDA district office. Class I recalls (serious health hazard) may require FDA notification before initiation in some cases.
What is the difference between a recall and an FSCA?
In the US, FDA uses 'recall' for any correction or removal to address a violation. In the EU, FSCA (Field Safety Corrective Action) is the EU MDR term for actions taken to reduce a risk of death or serious deterioration in health. Both terms cover voluntary market withdrawals, corrections in the field, and customer notifications.
What format are the documents?
All documents are editable Word templates formatted for regulatory submission and customer communication.
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For informational purposes only. Not legal or regulatory advice. Legal