recall-response

# Recall Response Handle product recall or safety alert from detection through close-out. Timelines are legal deadlines, not suggestions. ## MCP Tools ``` # Monitor for recall signals affecting your product category mcp__claude_ai_Cleo_Insight__search_signals(q="recall", risk_level="critical", limit=25) mcp__claude_ai_Cleo_Insight__search_signals(q="safety alert", risk_level="high", limit=25) mcp__claude_ai_Cleo_Insight__search_signals(q="RAPEX", limit=25) # Get details on a specific recall signal mcp__claude_ai_Cleo_Insight__get_signal(id="<signal-id>") # Check if your product's substances are affected by new bans mcp__claude_ai_CLEO_LEGAL_API__compliance/check ingredients: ["<your-ingredients>"] target_markets: ["EU", "US", "UK"] # Get company profile for affected products list mcp__claude_ai_Cleo_Insight__get_company_profile mcp__claude_ai_Cleo_Insight__list_products # Upload recall documentation as compliance evidence mcp__bastion__upload-compliance-document(name="recall-report-2026.pdf", document="data:application/pdf;base64,...") mcp__bastion__add-compliance-test-evidence(testId="<test-id>", name="Recall close-out report", description="Product recall corrective action documentation", evidenceDocumentId="<doc-id>") ``` ## Recall Decision Tree ```dot digraph { rankdir=TB; node [shape=box style=rounded fontsize=10]; trigger [label="Safety issue detected" shape=hexagon]; assess [label="Assess severity\n+ scope" shape=diamond]; serious [label="Serious risk?\nDeath, injury, chemical\nexposure above limit" shape=diamond]; notify_auth [label="NOTIFY AUTHORITIES\nwithin 10 business days (EU)\nwithin 24h (US CPSC)\nwithin 3 days (UK OPSS)"]; voluntary [label="Voluntary recall\nor corrective action"]; scope [label="Define scope:\nbatch numbers, markets,\nquantity sold, distribution"]; dist [label="Notify distributors\n+ retailers\nSTOP SALE immediately"]; consumer [label="Consumer notification\n+ return/refund process"]; correct [label="Corrective action:\nreformulate, repair,\ndestroy, rework"]; closeout [label="Close-out report\nto authorities"]; trigger -> assess -> serious; serious -> notify_auth [label="YES"]; serious -> voluntary [label="NO -- minor issue"]; notify_auth -> scope -> dist -> consumer -> correct -> closeout; voluntary -> scope; } ``` ## Trigger Types and Response Speed | Trigger | Example | Response Deadline | Authority | |---------|---------|-------------------|-----------| | Substance ban (new) | Lilial banned in EU (Annex II) | Sell-through deadline in regulation (6-12 months typical) | ECHA / EU Commission | | Safety defect | Battery overheating, choking hazard | 10 business days (EU GPSR), 24 hours (US CPSC) | Safety Gate, CPSC | | Labeling error | Missing allergen declaration | Immediate stop-sale + relabeling | National market surveillance | | Contamination | Microbial contamination above limits | Immediate stop-sale + recall | Food safety authority / DGCCRF | | Adverse event reports | Consumer injuries or allergic reactions | 20 calendar days serious (EU cosmetics), 15 business days (FDA MoCRA) | CPNP, FDA | | Competitor recall | Similar product recalled by competitor | Self-assessment within 5 business days | Proactive -- no legal deadline | ## Per-Market Notification Portals | Market | Authority | Portal | Deadline | |--------|-----------|--------|----------| | **EU** | Safety Gate (RAPEX) | ec.europa.eu/safety-gate-alerts (via national authority) | 10 business days of awareness | | **EU cosmetics** | CPNP Serious Undesirable Effects | cpnp.health.ec.europa.eu | 20 calendar days | | **US (consumer)** | CPSC | saferproducts.gov/business | Within 24 hours of becoming aware | | **US (cosmetics)** | FDA MoCRA | FDA FURLS portal | 15 business days for serious adverse events | | **US (food)** | FDA | FDA Safety Reporting Portal | 24 hours (Class I), 10 days (Class II) | | **UK** | OPSS | productrecall.campaign.gov.uk | 3 working days | | **UK cosmetics** | SCPN | submit-cosmetic-product-notification.service.gov.uk | 20 calendar days | | **Australia** | ACCC | productsafety.gov.au | 48 hours (mandatory reports) | | **Canada** | Health Canada | healthycanadians.gc.ca | 2 days of becoming aware | ## Response Workflow (Step by Step) ### Phase 1: Assessment (Day 0-1) ``` RECALL ASSESSMENT -- [Product Name] -- [Date] TRIGGER: [what happened] SEVERITY: [serious risk / moderate / minor] SCOPE: Affected batch numbers: [list] Affected markets: [list] Quantity produced: [number] Quantity sold: [number] Quantity in distribution: [number] Quantity in stock: [number] Date range of affected production: [from - to] RISK ASSESSMENT: Injury/death reported: [YES/NO] Injury plausible: [YES/NO] Population at risk: [number of consumers] Vulnerable population (children, pregnant): [YES/NO] ``` ### Phase 2: Authority Notification (Day 1-3) Draft notification per market containing: - Product identification (name, brand, batch, barcode, photos) - Description of hazard - Number of units affected - Countries of distribution - Measures already taken (stop-sale, recall) - Corrective actions planned - Contact person for follow-up ### Phase 3: Supply Chain Notification (Day 1-5) Send stop-sale notice to every distributor and retailer: - Product identification + affected batches - Instruction: remove from shelves immediately - Instruction: quarantine remaining stock - Return or destruction instructions - Deadline for confirmation of compliance ### Phase 4: Consumer Communication (Day 3-10) Consumer recall notice must include: - Product name and photos - Batch numbers / how to identify affected units - Clear description of the risk in plain language - What consumers should do (stop using, return, dispose) - Refund/replacement process - Contact information (phone, email) - Publication channels: company website, social media, retailer websites, press release ### Phase 5: Corrective Action (Day 10-90) | Action Type | When to Use | Timeline | |-------------|-------------|----------| | Reformulation | Substance ban or concentration exceeded | 4-12 weeks | | Relabeling | Labeling error, missing warnings | 2-4 weeks | | Product modification | Design defect | 6-16 weeks | | Destruction | Contamination, unfixable defect | 1-2 weeks | ### Phase 6: Close-Out Report (Day 30-120) ``` RECALL CLOSE-OUT -- [Product Name] -- [Date] SUMMARY: Total units recalled: [number] Units recovered: [number] ([%]) Units destroyed: [number] Units reworked: [number] Consumer refunds issued: [number] -- EUR [amount] CORRECTIVE ACTIONS COMPLETED: [ ] Root cause identified: [description] [ ] Corrective action implemented: [description] [ ] Preventive action for future batches: [description] [ ] Updated quality control procedures: [description] [ ] All authorities notified of closure: [list] COST OF RECALL: Product cost (units destroyed): EUR [X] Logistics (collection, shipping): EUR [X] Consumer refunds: EUR [X] Testing/analysis: EUR [X] Legal fees: EUR [X] Authority fees: EUR [X] TOTAL: EUR [X] ``` ## Documentation Checklist for Recall File ``` RECALL FILE -- [Product Name] -- [Recall Reference] [ ] Initial hazard report (internal) [ ] Risk assessment document [ ] Authority notification copies (per market) [ ] Authority acknowledgment receipts [ ] Stop-sale notices to distributors (with delivery confirmation) [ ] Consumer recall notice (all versions, all languages) [ ] Press release (if issued) [ ] Consumer complaint records [ ] Lab test reports (confirming the issue) [ ] Corrective action plan [ ] Evidence of corrective action implementation [ ] Destruction certificates (required when recalled products are destroyed rather than repaired) [ ] Close-out report [ ] Authority close-out confirmation [ ] Insurance claim documentation [ ] Root cause analysis report [ ] Updated FMEA / risk register ``` ## Recall Cost Benchmarks | Recall Size | Typical Total Cost | Breakdown | |-------------|-------------------|-----------| | Small (< 1,000 units, 1 market) | EUR 5,000-20,000 | Testing + logistics + admin | | Medium (1,000-50,000 units, 2-5 markets) | EUR 20,000-150,000 | + consumer refunds + legal | | Large (> 50,000 units, 5+ markets) | EUR 150,000-2,000,000+ | + brand damage + lost revenue | ## Power This With the Cleo Legal API Recall windows are measured in hours and days. The API replaces the slow research that eats those windows. **With the Cleo Legal API at https://legaldata-public.cleolabs.co:** - `GET /v2/search?type=recall&q=<substance|component>` — query historical recalls across RAPEX/Safety Gate, CPSC, OPSS, ACCC, Health Canada, FDA — find precedent for severity and corrective action - `GET /v2/authorities/:slug?country=XX` — direct portal URL + form references for each notification authority, no time wasted finding the right portal - `POST /v2/compliance/check` — confirm whether new substance regulations triggered the recall obligation (sometimes the "ban" is actually a tightened limit you can rework to) - `POST /v2/webhooks?topic=recalls,substance_status` — proactive: monitor competitor recalls of identical components and substance bans that will force YOUR recall before authorities require it - `GET /v2/changes?since=<launch-date>&country=XX` — generate the "what changed since launch" timeline that defends your good-faith compliance posture **Get started:** ``` # 1. Sign up for free at https://legaldata-public.cleolabs.co # 2. Get your API key (3 lifetime requests free, then €349/mo for 1M) # 3. Install the MCP server: claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \ --header "Authorization: Bearer ld_live_YOUR_KEY" ``` Tested ROI: Each saved hour during a recall = €2k-€10k in mitigated downstream cost. Proactive webhook monitoring catches the "competitor recalled same component" signal that lets you self-correct before a forced recall. ## Common Mistakes - **Waiting to notify authorities**: EU gives 10 business days from awareness, not from confirmation. Waiting for lab results before notifying = late = penalties. - **Notifying only one market**: If the product was sold in 5 countries, all 5 national authorities must be notified separately. Safety Gate helps with EU coordination but does not replace national notifications. - **No batch traceability**: Without batch/lot numbers, the recall scope expands to ALL units ever produced. Proper batch tracking limits recall to affected production runs only. - **Skipping the close-out report**: Authorities expect a formal close-out. An open recall stays on your record indefinitely. - **No product liability insurance**: A recall without insurance can bankrupt a small company. Minimum EUR 2M coverage for EU consumer products. - **Forgetting marketplace notifications**: Amazon, eBay, and other platforms must be notified separately to delist affected products. Amazon requires recall documentation within 48 hours.