Do we still report if we filed an MDR?

MDR and 806 are different processes. An MDR does not automatically replace 806 obligations—your provider can advise based on the facts.

Recall & 21 CFR 806 Corrections/Removals Support

Q: What's the difference between a recall, correction, and removal?

A correction fixes a device in the field; a removal takes it out of where it is used or distributed. Recall is a broader term often used for actions to address a product problem.

Q: Do all recalls require a 21 CFR 806 report?

No. FDA states that if there is no risk to health, a report may not be required, but records must be kept. Reporting is required for certain corrections/removals (e.g., risk-to-health or certain violations that may present a risk).

Q: When does the "10 working days" clock start?

When required, the report must be submitted within 10 working days from the time the firm initiates the correction or removal.

Q: What should be included in an 806 report?

A clear description of the device and issue, scope (lots/serials/UDI), distribution, reason/risk rationale, actions taken, and your communication plan—aligned with FDA's reporting elements.

Q: How do we communicate with consignees/customers?

Providers can help draft notification letters, instructions, response tracking, and effectiveness checks to support execution and closure.

Field action triage + reporting + execution

When reporting is required, the 806 report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal.

Decision tree (reportable vs record-only)
806 report drafting
Customer/consignee communications

Request recall/806 support

We’ll match you with recall experts for strategy, 806 reporting, and execution.

Contact name *

Email *

Company *

Device name

Product code (if known)

Market status * Action type *

Initiation date *

Risk level *

Where distributed * Units affected (approx.) Lot/serial/UDI (optional but encouraged) Description of issue + patient/user risk summary * Supporting docs (optional)

PDF or Word. Max 10 MB total. Complaints, investigation summary, draft communication, etc.

Any injuries? MDR numbers (if any) Consignee list available? Proposed remedy FDA already contacted? Recall coordinator involved?

I agree to be contacted and for my info to be shared with matched providers.

Recall vs correction vs removal vs market withdrawal

Recall means a firm’s removal or correction of a marketed device that FDA considers to be in violation of the law. Correction is repair, modification, or other action without physically removing the device. Removal is physically removing the device from where it is used or sold. Market withdrawal is a firm’s removal or correction of a device that has no violation (e.g. minor quality issue). Plain English: recall/correction/removal often trigger 806 reporting when there is a risk to health; market withdrawal may not.

When 21 CFR 806 reporting is required

Reporting is required when a correction or removal is undertaken to reduce a risk to health, or to remedy a violation of the Act that may present a risk to health. If the action is not for one of those reasons (e.g. market withdrawal for a minor issue), it may be record-only. An expert can help you determine reportability.

Timing: 10 working days from initiation + amendments

The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal (when required). If you later expand the action to more lots or additional locations, FDA expects an amendment to the report.

What to include in an 806 report

High-level checklist aligned with FDA’s expectations: identity of the device, reason for the correction/removal, risk to health, number of units affected, dates and distribution information, consignee communications, and corrective actions. FDA’s guidance and forms provide a detailed list; recall experts can help you assemble the report.

Execution checklist

Communications (consignees, users, FDA), effectiveness checks, traceability (lots/serials/UDI), CAPA linkage, and documentation. Recall experts can support strategy, 806 drafting, consignee letters, and execution.

How matching works

You submit the form above. We triage within 1 business day.
We match you with 1–3 vetted recall/regulatory providers based on action type, initiation date (10-day deadline), distribution footprint, and severity.
You work with them directly. We are a marketplace; we do not provide legal or regulatory advice.

Frequently asked questions

What's the difference between a recall, correction, and removal?

A recall is generally an action to address a product issue; "correction" fixes product in the field; "removal" takes product out of where it's used/distributed.

Do all recalls require a 21 CFR 806 report?

No. FDA notes reporting is required for certain corrections/removals (e.g., risk-to-health), and if no risk-to-health is involved, reporting may not be required but records must be kept.

When does the "10 working days" clock start?

From the time the firm initiates the correction or removal (when reporting is required).

What should be included in an 806 report?

A clear description of the device, the issue, the reason/risk rationale, scope (lots/serials/UDI), distribution, actions taken, and your communication plan (high level).

What if we expand the scope later (more lots/units)?

You typically update/amend the report and communications to reflect expanded scope and actions.

Do we still file if we submitted an MDR?

They're different processes; MDR reporting doesn't automatically replace 806 obligations—your matched expert can advise based on facts.

How do we communicate with consignees/customers?

Providers can help draft consistent notification letters, instructions, and response tracking to support effectiveness checks.

Can you help with effectiveness checks and tracking?

Yes—this is a core part of recall execution: tracking responses, returns/repairs, and closure evidence.

What if distribution is global (not just U.S.)?

We can match you to teams that handle U.S. FDA actions alongside EU/UK/other authority requirements.

How fast can you start?

Same-day intake for urgent cases; matching prioritizes initiation date + patient/user risk.

This page is for informational purposes only and does not constitute legal advice. Cruxi is a marketplace/matching service; we are not FDA and are not a law firm. We do not guarantee outcomes. We match you with vetted providers who may assist with recall and 806 reporting. See our Privacy Policy for how we share data with matched providers.