Compliance marketplaceHow Cruxi worksFor compliance providersDeal Desk Regulatory Dashboard Free QMSR Scan Consultant Dashboard Provider Dashboard Get Listed – Consultant Get Listed – Provider
Deal Desk

Marketplace & guides

Medical Device Deal Desk Medical Device M&A (Deal Paths) Medical Device Acquisitions Medical Device Acquisitions (Marketplace) Medical Device Company for Sale Distribution Opportunities Medical Device Exit Options Post Buying Interest List an Opportunity Acquisition & Distribution (Long Guide)
510(k) & Regulatory

Regulatory Services

Free 510(k) Device Assessment 510(k) Regulatory Pathway Assessment 510(k) Modification Assessment 510(k) Traditional Submission QMSR / ISO 13485 Readiness Platform Free QMSR Readiness Scan FDA Consultant & Medical Device Consulting 510(k) Cybersecurity Consultants Los Angeles Free 510(k) Checklist Clinical Trial Insurance (UK, EU, US) Clinical Trial Insurance Cost Calculator

510(k) Services

FDA 510k Consultant Classification Predicate Analysis Regulatory Assessment eSTAR Editor Packaging

Electrical Safety

Arc Flash & One-Line Bids As-Built Electrical Drawings Arc Flash Study Quote & Cost 510(k) Electrical Safety & EMC Testing

510(k) Resources

510(k) Demo Project FDA Database for Research Regulatory Analytics eSTAR Guide FDA eSTAR Templates Predicate Analysis Substantial Equivalence Cybersecurity (SAMD) Risk Analysis (ISO 14971) Fees & Timeline Labeling & IFU FDA 510k Consultant vs AI Checklist Guide

510(k) Microservices

Classification Matching Predicate Finding Regulatory Assessment RTA Check

AI Knowledge Base

AI Literature Review Generator Dissertation Literature Review Systematic Review Software Free Citation Generator Universal Toolbar
EU/UK Representatives

Browse Directories

All Provider Directories FDA 510(k) Submission Services marketplace FDA 510(k) Consultant Directory

Platform Directories

EUDAMED M2M Providers eIFU & Implant Card Platforms FDA GUDID Submission Tools

EU/UK Data & Privacy Reps

GDPR Article 27 Representative Do I Need a GDPR Article 27 Representative? GDPR Article 27 Cost Calculator Article 27 Representative Services Article 27 Pricing Comparison GDPR Article 27 Representative List Swiss FADP Representative Do I Need a Swiss FADP Representative? Swiss FADP Representative Cost Calculator Swiss FADP Representative List GPSR Responsible Economic Operator Do I Need a GPSR Responsible Person? GPSR Cost Calculator GPSR FAQs GPSR Marketplace Listing Readiness Calculator GPSR Technical File Readiness Scorecard GPSR Economic Operator Risk Estimator WEEE / EPR Compliance VAT Fiscal Representative DSA Article 13 Legal Representative REACH Only Representative

EU Cosmetics

EU Cosmetics Responsible Person EU/UK Responsible Person (RP/UK RP) CPSR Support PIF Preparation CPNP/SCPN Support Regulatory Consulting + Formula Compliance Testing Coordination & Management Cosmetics RP List Cosmetics Compliance Tools (EU/UK) Cosmetic Launch Diagnostic (60 sec) EU Ingredient Scan EU Claims Risk Scan Amazon Suppression Diagnosis Cosmetic Contract Manufacturing Manufacturing Tools & Guides Manufacturing RFQ Template Generator Private Label Cost Calculator Capability Matcher Wizard
EU Medical & Global Reps

EU/UK Medical Representatives

EU Authorized Representative Do I Need an EU Authorized Representative? EU Authorized Representative Cost Calculator EU Authorized Representative List UK Responsible Person Swiss Authorized Representative Swiss CH-REP Provider Directory Do I Need a CH‑REP? CH‑REP Cost Calculator CH-REP Mandate Scope Gap Calculator CH-REP Transition Timeline Calculator CH-REP Annual Budget Calculator PRRC as a Service Do I Need a PRRC? PRRC Cost Calculator PRRC List

Medical Device Support

EUDAMED Registration Support Importer & Distributor Compliance FDA QMSR Transition & Inspection Readiness eQMS Software Comparison Medical Device Cybersecurity EU AI Act Authorized Representative (GPAI) EU AI Act High-Risk AI Compliance EUDAMED Onboarding & Data Registration

Non-EU Regulatory Reps

FDA U.S. Agent FDA U.S. Agent Cost Calculator U.S. Agent Compliance Checker U.S. Agent Selection Scorecard FDA U.S. Agent List CBAM Verification AU TGA Sponsor Japan MAH / DMAH Brazil ANVISA Local Representative Compare +50 Brazil ANVISA Local Rep Providers ANVISA Local Representative Total Cost Calculator ANVISA Registration Timeline Risk Estimator ANVISA Documentation Readiness Scorecard ANVISA Portuguese Labeling Readiness Calculator ANVISA Change Impact Calculator ANVISA Post-Market Workload Calculator
Testing & Enforcement

Testing Services

Electrical Safety + EMC Testing (IEC 60601) Wireless / RF Testing (FCC / RED / ISED) Biocompatibility Testing (ISO 10993 Program) Sterilization + Microbiology Validation Packaging + Shelf-life + Distribution Testing Usability / Human Factors Testing

FDA Enforcement & Recall

FDA Import Alert & Detention Assistance Form 483 Response Team Form FDA 483 Response Provider Directory Form FDA 483 Readiness Calculator Form FDA 483 CAPA Timeline Calculator Form FDA 483 Remediation Cost Calculator Recall & 21 CFR 806 Support Recall & 21 CFR 806 Provider Directory 21 CFR 806 Reportability Decision Calculator Recall Action Timeline Calculator Recall & 806 Remediation Cost Calculator

FDA U.S. Agent Information

Medical Device Establishment Registration 21 CFR 807.40 Requirements U.S. Agent vs Official Correspondent Change U.S. Agent in FURLS U.S. Agent Address Requirements Confirm Notification Receipt Code U.S. Agent Role for Inspections U.S. Agent for IVD Manufacturer U.S. Agent for Contract Manufacturer U.S. Agent Cost Per Year Affordable U.S. Agent Service U.S. Agent for Foreign Drug Establishment 21 CFR 207.69 U.S. Agent Food Facility Registration U.S. Agent Food Facility Renewal Confirmation

Cost Calculators

Biocompatibility Testing Cost Calculator Biocompatibility Testing Labs in India EU/UK Cosmetics RP Cost Calculator
Company & Legal
About Cruxi Contact Pricing & Credits Editorial Posting & Sponsorships Blog Careers

Use Cases

Medical Device 510(k) Submission QMSR / ISO 13485 Readiness Free QMSR Readiness Scan PhD & Masters Students Medical Research Academic Writing Legal Teams

Consulting & Resources

FDA 510k Consultant Network FDA Consultant Near Me & Medical Device Consulting 510(k) Cybersecurity Consultants Los Angeles Find 510k Consultants by Specialty FDA Mock Audit Consultants ISO 13485 Consultants ISO 14971 Consultants 510k Consultant Pricing Models 7 Red Flags When Hiring a 510k Consultant Combine 510k Consultants with AI Tools How to Scope a 510k Consultant Project

General Resources

Traditional vs AI Methods Features FAQ 510k Consultant Engagement Guide (PDF)

Legal & Policies

How Cruxi Protects Your Data Security GDPR Compliance Privacy Policy Compliance & Contacts Trust & Listings Cookie Policy Subprocessors EU/UK Article 27 Representative Data Subject Request Data Processing Agreement Terms of Service Consultant Terms Provider Terms Book Now T&C (Clients) Book Now T&C (Providers) Refund Policy Payment Terms Credit Usage Policy Cancellation Policy Support Policy

For Consultants

Apply to Consultant Network

For Service Providers

Join Provider Network Apply Now

Account

Provider Dashboard Consultant Dashboard
About Contact Pricing Blog All Directories Privacy Terms

Reported risk evidence comparison

Toys: optical output — reported risk evidence

The acquired cohort contains 46 official alert references published from 2005-02-11 to 2026-06-19. This page compares 8 selected, distinct product descriptions, including toy flashlight, toy projector, plastic toy with led. The other 38 records still contribute to the cohort counts but are not displayed: descriptions may repeat, lack the display inputs, or fall outside the eight-description display limit. The recorded risks raise separate evidence questions about optical output. Compare the product features and dated findings below before scoping an investigation. These historical observations do not determine your product’s compliance or a market failure rate.

Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.

Dated official observations

Compare the product features and reported failure mechanism

The source wording below describes the reported case at that time. Read each complete report before using it in an investigation.

Toy flashlight · SR/01730/26

Report published 2026-06-19 · notifying country France · reported origin People's Republic of China

Reported product description
Pink toy flashlight in which perforated discs (supplied with the toy) can be inserted to project an image (10 discs). [1]
Reported risk explanation
The LED is too powerful. As a result, direct viewing of the laser beam could cause damage to sight. The product does not comply with the requirements of the Toy Safety Directive nor with the European standard EN 62115. [1]
Reported measures, verbatim
Type of economic operator taking notified measure(s): OtherCategory of measure(s): Removal of this product listing by the online marketplaceDate of entry into force: 22/04/2026Type of economic operator taking notified measure(s): OtherCategory of measure(s): Warning consumers of the risksDate of entry into force: 27/06/2026 [1]

Read the official alert ↗

Toy projector · A12/03648/24

Report published 2024-12-13 · notifying country Germany · reported origin Unknown

Reported product description
Starry sky toy projector in the shape of an astronaut, product dimensions: 12.9 cm deep x 16.3 cm wide x 22.9 cm height. Product sold online, in particular via Amazon (ASIN B0CHYPVWHV) [2]
Reported risk explanation
The laser beam is too powerful (measured value up to 4.27 mW) and the product is not adequately labelled. Direct viewing of the laser beam could cause damage to sight. The product does not comply with the requirements of the Toy Safety Directive nor with the European standards EN 60825-1 and EN 62115. [2]
Reported measures, verbatim
Type of economic operator taking notified measure(s): OtherCategory of measure(s): Removal of this product listing by the online marketplaceDate of entry into force: Unknown [2]

Read the official alert ↗

Plastic toy with LED · A11/00076/22

Report published 2022-07-01 · notifying country Ireland · reported origin People's Republic of China

Reported product description
The toy consists of a thin piece of bright green plastic with a LED light at one end and 'wings' at the other end. Batteries are not replaceable. [3]
Reported risk explanation
The laser beam located in the LED light at one end of the toy is too powerful (0.49mW at a distance of 8 cm). Direct viewing of the laser beam could cause damage to sight. The product does not comply with the requirements of the Toy Safety Directive nor with the European standards EN 60825-1 and EN 62115. [3]
Reported measures, verbatim
Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 27/04/2022 [3]

Read the official alert ↗

Toy gun · A12/01516/22

Report published 2022-02-25 · notifying country France · reported origin Hong Kong

Reported product description
Toy gun, equipped with a laser sight (LED), and spinning top: the gun is used to trigger the spinning top. Product sold online, in particular via Allegro (unique identifier: 17167980912). [4]
Reported risk explanation
The LED laser sight on the top of the toy gun is too powerful (measured value: 1.23 mW). Direct viewing of the laser beam could cause damage to sight. The product does not comply with the requirements of the Toy Safety Directive nor with the European standard EN 62115. [4]
Reported measures, verbatim
Type of economic operator taking notified measure(s): ImporterCategory of measure(s): Recall of the product from end usersDate of entry into force: 04/01/2022Type of economic operator taking notified measure(s): OtherCategory of measure(s): Removal of this product listing by the online marketplaceDate of entry into force: Unknown [4]

Read the official alert ↗

Plastic frisbee with LEDs · A11/00100/20

Report published 2020-11-20 · notifying country France · reported origin People's Republic of China

Reported product description
23 cm large green plastic frisbee with LEDs. [5]
Reported risk explanation
The laser beam located in the internal LED at the centre of the frisbee is too powerful (1.96mW against a limit of 0.39mW). Direct viewing of the laser beam if the LED is taken out of the frisbee could cause damage to sight. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 62115. [5]
Reported measures, verbatim
Type of economic operator taking notified measure(s): OtherCategory of measure(s): Ban on future sales.Date of entry into force: Unknown [5]

Read the official alert ↗

Plastic toy gun · A12/1681/19

Report published 2019-11-08 · notifying country Slovenia · reported origin People's Republic of China

Reported product description
Plastic toy gun with LED and small plastic round projectile. [6]
Reported risk explanation
The laser beam (blue LED light) is too powerful.If a child directs the LED light to the eye of another person it may cause damage to sight. Moreover, the kinetic energy of the projectile fired from the toy gun is too high and can lead to eye injuries.The product does not comply with the requirements of the Toy Safety Directive and the relevant European Standards EN 71-1 and 60825-1. [6]
Reported measures, verbatim
Type of economic operator taking notified measure(s): DistributorCategory of measure(s): Recall of the product from end usersDate of entry into force: 24/10/2019 [6]

Read the official alert ↗

Toy gun · A12/0872/18

Report published 2018-06-29 · notifying country Slovenia · reported origin People's Republic of China

Reported product description
Plastic gun with different kinds of bullets (water bomb, foam bomb) and has a red laser (infrared sight, blue light). [7]
Reported risk explanation
The laser beam is too powerful and the suction cups can easily detach from the projectiles. If a child directs the gun laser to the eye of another person it could cause damage to sight. If a child puts the projectile in the mouth, the suction cup may detach and obstruct the airways.In addition, the sound pressure level is too high. This can cause damage to hearing.The product does not comply with the requirements of the Toy Safety Directive and the relevant European standards EN 71-1 and EN 60825-1. [7]
Reported measures, verbatim
Type of economic operator to whom the measure(s) were ordered: ImporterCategory of measure(s): Recall of the product from end usersDate of entry into force: 07/06/2018 [7]

Read the official alert ↗

Toy bow and arrows · A12/0373/18

Report published 2018-03-09 · notifying country Hungary · reported origin People's Republic of China

Reported product description
The plastic archery set consists of a bow with laser aimer and three arrows with suction cups. Packaging: blister pack on cardboard. [8]
Reported risk explanation
The laser beam is too powerful. Direct viewing of the laser beam could cause damage to sight. Moreover, the kinetic energy of the arrows is too high. This could cause injuries to the eyes.The product does not comply with the requirements of the Toys Directive and the relevant European standards EN 62115 and EN 71-1. [8]
Reported measures, verbatim
Type of economic operator to whom the measure(s) were ordered: DistributorCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: UnknownType of economic operator to whom the measure(s) were ordered: DistributorCategory of measure(s): Recall of the product from end usersDate of entry into force: 23/01/2018 [8]

Read the official alert ↗

What this acquired cohort contains

46 distinct official alert references, published between 2005-02-11 and 2026-06-19. Counts describe the acquired reports, with no market denominator.

Report yearRecorded alerts
20054
20062
20081
20096
20105
20113
20122
20134
20142
20152
20161
20174
20182
20192
20201
20222
20231
20241
20261

Recorded risk labels within this evidence task

Label combinations are source facts within one comparison; they do not create separate guides with identical preparation tasks.

Source selection, exclusions and calculation method

Filter the acquired, completely parsed English weekly XML releases. Deduplicate official alert references. Group by product category and the complete set of conditional evidence-question topics supported by actual risk text. Risk-label combinations remain recorded cohort facets and do not create buyer intents. Brand, product name, model, origin, notifying country, measurement-only changes and different wording of the same questions do not create intents. Unrecognized mechanisms stay internal for enrichment. Count report years and notifying countries deterministically. Display at most eight newest descriptions with at least 40 characters after whitespace normalization, nonempty reported measures and distinct casefolded descriptions; break date ties by official identifier. All cohort records count even if their description is shorter or not displayed. This is not a representative sample. Counts concern this acquired corpus only.

One acquired version per official public alert reference. Display at most eight newest distinct product descriptions whose normalized whitespace-collapsed text contains at least 40 characters and has nonempty reported measures; ties sort by official identifier. The complete cohort includes shorter descriptions. This is an explicit display selection, not a representative sample.

8 distinct descriptions displayed; 38 cohort records not displayed. Missing fields: {'measures': 5}.

These are selected, dated enforcement observations in the acquired weekly reports, not a random market sample, market-wide failure rate, proof of current product status, or a determination about your product. Notification country is not a complete sales-market or jurisdiction-coverage field. A quoted legal/standard reference is the report’s statement, not independently verified current law or a mandatory test panel.

Calculation safety-gate-evidence-comparison-10; units recorded alerts; no incidence denominator.

Turn the reported failure mechanism into a scoped investigation

Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.

  1. Optical output and accessible-use configuration — what evidence do we have?

    Identify the optical source, rated output and accessible operating modes, users and protective controls. Request configuration-specific evidence and a supported applicability review rather than inferring a classification or safe output from another alert.

    Useful evidence: Source/output specifications, operating modes, access/protection design, intended users and existing measurement evidence.

    Reported context: [1], [2], [3], [4], [5], [6], [7], [8]

  2. Can we trace the affected component, formula or design revision across our supplied products?

    Compare the reported descriptions with your own identifiers and change records. Treat missing or “Unknown” source fields as unresolved; they do not establish that no action was needed.

    Useful evidence: Product identifiers, revision history, supplier/batch traceability and market/operator records.

  3. Who would own an evidence review and any resulting corrective-action decision?

    Read the reported measures as historical observations. Establish your own operator roles, sector-specific rules, decision owner and communication responsibilities before adopting another case’s response.

    Useful evidence: Supply-chain responsibility map, applicable-law review, investigation scope and documented decision/communication workflow.

Work packages and dependencies

Questions for providers

Sources and data dates

Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.

Prepare an editable project brief

Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.

Choose work packages to discuss

Compare Find GPSR Responsible Person (EU/NI) | Compare & Get Quotes