---

name: recall-response description: Use when a product recall or safety alert is triggered, a substance is newly banned in a market where you sell, a safety defect is discovered, a contamination report is received, or when monitoring competitors' recalls for proactive risk assessment

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

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.