Recall · Mock recall · FDA · FSMA 204
Recall software for mock and real recalls.
Trace a lot forward and back, see affected customers, and record the actions your team takes.
Automated Customer Notification with Delivery + Response Tracking
Email + portal notifications with read receipts, acknowledgement capture, and quantity-returned tracking against quantity-shipped.
Regulator Reporting Pack
FDA Reportable Food Registry, USDA FSIS, Health Canada, EU RASFF and MHRA formats generated from the same underlying record.
Mock Recall Scheduler with Scorecard
Schedule quarterly / annual mock recalls, log elapsed time, capture the auditor's scorecard, trend across sites.
What goes wrong today3 common problems
Mock Recall Takes 4 Days, Not 4 Hours
The auditor times you. You fail. Because the trace lives in spreadsheets that nobody has opened in six months.
Customer notification is a spreadsheet blast
No delivery confirmation, no response tracking, no evidence you actually reached the affected accounts.
Effectiveness Check Never Closes
You send the notice, but you can't prove the product came back or was destroyed.
How it works, step by step6 steps
Recall lifecycle.
- Event Opens Recall. Complaint, OOS, deviation or external signal opens recall workflow.
- Consignees and Quantities. Traceability engine computes affected consignees and quantities.
- Class Assigned. Class I/II/III with rationale.
- Regulator & Customers. Per-jurisdiction tasks with clocks.
- Quantities Returned. Reconciled against distributed.
- Effectiveness signed. Effectiveness recorded; CAPA raised if warranted.
What to look for when choosing
Recall systems live in the reaction time. If mock and real recalls take longer than the regulator's clock, you're behind before you start.
Mock Recall Drill Cadence
Does the system enforce and record mock recalls at required cadence? Scheduled with SLA; misses raise a finding record.
One-Up / One-Down Trace
Can affected consignees be listed?
Classification workflow
Class I / II / III with rationale? Classification workflow with rationale capture.
Regulator Notification Tracking
Are notifications tracked per jurisdiction with due dates? Per-jurisdiction task set with clock.
Effectiveness Check
Does the system verify quantity recovered vs distributed? Recovered vs distributed reconciled with signed effectiveness.
V5 Compared with Other Approaches
Recall approaches.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Mock recall time | Day+ | Hours | Minutes |
| Consignee list | Manual | Report | |
| Classification workflow | Ad-hoc | Static | Native with rationale |
| Effectiveness | Manual | Optional | Reconciled and signed |
Regulations this supportsYour quality team stays responsible for compliance
Recall clauses.
21 CFR Part 7
Recall workflow implements Part 7 process end-to-end.
21 CFR 806
Device 806 reports generated in-system.
EU MDR Article 87
FSCA lifecycle supported.
Standards Referenced
- 21 CFR 7 (FDA recall guidelines)
- FSMA 204 (Food Traceability Rule)
- 21 CFR 806 (medical device corrections & removals)
- EU MDR Article 89 (field safety corrective actions)
- USDA FSIS Directive 8080.1 (recall procedures)
Common questions2 answers
- Does V5 handle FSMA 204 traceability?
- Yes — the underlying traceability engine captures Key Data Elements at Critical Tracking Events for FTL-listed foods and exports the sortable spreadsheet FDA requires within the 24-hour rule.
- What about medical device field safety corrective actions?
- V5 handles 21 CFR 806 corrections and removals and EU MDR Article 89 FSCA notifications with the same recall engine — device serialisation and UDI are first-class.