Is a correction cheaper than a removal?

Usually per device, because a correction repairs, relabels or inspects the device where it is, without return freight. Enter your on-site correction cost as the retrieval and replacement cost; notification and fixed costs still apply.

Do I have to report a recall to FDA?

Yes, if started to reduce a risk to health or remedy a violation that may present one. Section 806.10 requires a written report within 10 working days of starting it. The report lists devices distributed and every consignee, the counts this calculator uses.

What effectiveness check level should I budget for?

The one your recall strategy sets: section 7.42 defines Level A as 100% of consignees contacted, Level C as 10% and Level D as 2%. At lower levels, reduce the per-consignee cost to match.

Why count devices shipped rather than devices built?

Because only distributed devices need notification and retrieval. A lot that never left your control is a stock recovery, not a recall, under section 7.3. Take shipped quantities by lot from distribution records.

MedTech Manufacturing calculator

Recall Exposure Cost Calculator

Estimate the direct cost of a device recall before you set a reserve or decide whether tighter lot traceability pays. You need devices and consignees in scope, per-device and per-account costs, fixed program cost and your reserve.

What this calculator does

Direct cost of notifying consignees and retrieving or replacing devices in a recall, and whether your recall reserve covers it.

Formula used

Retrieval and replacement cost = devices in field × retrieval and replacement cost per device
Consignee notification cost = consignees to notify × notification cost per consignee
Recall exposure cost = retrieval and replacement cost + consignee notification cost + fixed recall cost
Reserve headroom = recall reserve − recall exposure cost; recall cost per device = recall exposure cost ÷ devices in field
Device-driven share = retrieval and replacement cost ÷ recall exposure cost

Inputs explained

Devices in Field: Devices from affected lots shipped to consignees, from distribution records.
Retrieval and Replacement Cost per Device: Return freight, handling and destruction, plus a replacement at standard cost.
Consignees to Notify: Direct accounts that received affected devices: hospitals, distributors, clinics.
Notification Cost per Consignee: Recall letter, tracked delivery, response follow-up and effectiveness check.
Fixed Recall Cost: Health hazard evaluation, FDA report, root cause, legal and recall coordination.
Recall Reserve: Accrued reserve or recall insurance limit to test against; 0 skips.

How to use the result

Best suited to sizing a recall reserve or insurance limit, valuing lot traceability that narrows recall scope.
Excludes lost sales, held shipments, litigation and product liability; add any your reserve covers to fixed recall cost. Does not set recall class or depth; FDA classifies a recall from its health hazard evaluation.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

Is a correction cheaper than a removal? Usually per device, because a correction repairs, relabels or inspects the device where it is, without return freight. Enter your on-site correction cost as the retrieval and replacement cost; notification and fixed costs still apply.
Do I have to report a recall to FDA? Yes, if started to reduce a risk to health or remedy a violation that may present one. Section 806.10 requires a written report within 10 working days of starting it. The report lists devices distributed and every consignee, the counts this calculator uses.
What effectiveness check level should I budget for? The one your recall strategy sets: section 7.42 defines Level A as 100% of consignees contacted, Level C as 10% and Level D as 2%. At lower levels, reduce the per-consignee cost to match.
Why count devices shipped rather than devices built? Because only distributed devices need notification and retrieval. A lot that never left your control is a stock recovery, not a recall, under section 7.3. Take shipped quantities by lot from distribution records.

Last reviewed 2026-10-01.