{"data":{"slug":"fda-medical-device-recall-enforcement-quarterly-archive","title":"FDA Medical Device Recall Enforcement Quarterly Archive","summary":"Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.","buyer_outcome":"Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.","target_audiences":[],"use_cases":[],"industries":[],"geographies":[],"output_formats":[],"marketplaces":[],"marketplace_availability":[{"key":"gumroad","label":"Gumroad","status":"published","status_label":"Not Yet Published","action_label":"Not Yet Published","url":null,"clickable":false,"coverage":"application_covered"},{"key":"hetzner_object_storage","label":"Hetzner Object Storage","status":"uploaded","status_label":"Uploaded","action_label":"Uploaded","url":null,"clickable":false,"coverage":"application_covered"},{"key":"cloudflare","label":"Cloudflare Edge Commerce","status":"under_review","status_label":"Awaiting Marketplace Review","action_label":"Awaiting Marketplace Review","url":null,"clickable":false,"coverage":"application_covered"},{"key":"github_marketplace","label":"GitHub Marketplace","status":"under_review","status_label":"Awaiting Marketplace Review","action_label":"Awaiting Marketplace Review","url":null,"clickable":false,"coverage":"application_covered"},{"key":"google_workspace_marketplace","label":"Google Workspace Marketplace","status":"under_review","status_label":"Awaiting Marketplace Review","action_label":"Awaiting Marketplace Review","url":null,"clickable":false,"coverage":"application_covered"}],"primary_cta":null,"sample":{"rows":[{"state":"IL","status":"Ongoing","country":"United States","source_url":"https:\/\/api.fda.gov\/device\/enforcement.json?search=recall_number.exact%3A%22Z-2537-2026%22&limit=1","report_date":20260708,"recall_number":"Z-2537-2026","classification":"Class II","recalling_firm":"Medline Industries, LP","product_quantity":"333 kits","reason_for_recall":"The kits containing Huons Lidocaine HCL Injection USP 1% 10mg\/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.","voluntary_mandated":"Voluntary: Firm initiated","product_description":"Medline Convenience Kits:  1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF;   2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE;   3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK","distribution_pattern":"US Nationwide distribution.","recall_initiation_date":20260521},{"state":"IL","status":"Ongoing","country":"United States","source_url":"https:\/\/api.fda.gov\/device\/enforcement.json?search=recall_number.exact%3A%22Z-2538-2026%22&limit=1","report_date":20260708,"recall_number":"Z-2538-2026","classification":"Class II","recalling_firm":"Medline Industries, LP","product_quantity":"510 kits","reason_for_recall":"The kits containing Huons Lidocaine HCL Injection USP 1% 10mg\/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.","voluntary_mandated":"Voluntary: Firm initiated","product_description":"Medline Convenience Kits:  1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C;   2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C","distribution_pattern":"US Nationwide distribution.","recall_initiation_date":20260521},{"state":"IL","status":"Ongoing","country":"United States","source_url":"https:\/\/api.fda.gov\/device\/enforcement.json?search=recall_number.exact%3A%22Z-2539-2026%22&limit=1","report_date":20260708,"recall_number":"Z-2539-2026","classification":"Class II","recalling_firm":"Medline Industries, LP","product_quantity":"40 kits","reason_for_recall":"The kits containing Huons Lidocaine HCL Injection USP 1% 10mg\/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.","voluntary_mandated":"Voluntary: Firm initiated","product_description":"Medline Convenience Kits:  1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068;   2) BREAST BIOPSY PACK, Model Number: PHS234706I","distribution_pattern":"US Nationwide distribution.","recall_initiation_date":20260521}],"title":"Fda Device Recall Enforcement Record sample rows","fields":["recall_number","report_date","recall_initiation_date","classification","status","recalling_firm","product_description","reason_for_recall","product_quantity","distribution_pattern","voluntary_mandated","country","state","source_url"],"source":"product_output_contract","row_count":3,"sample_type":"captured_public_source","record_label":"fda_device_recall_enforcement_record","refreshed_at":"2026-07-21T13:52:06.000000Z","sample_status":"valid_public_sample","missing_reason":null,"sample_available":true},"schema_preview":{"fields":[{"name":"recall_number","type":"string","required":true,"description":"Recall number."},{"name":"report_date","type":"string","required":true,"description":"Report date."},{"name":"recall_initiation_date","type":"string","required":true,"description":"Recall initiation date."},{"name":"classification","type":"string","required":true,"description":"Classification."},{"name":"status","type":"string","required":true,"description":"Status."},{"name":"recalling_firm","type":"string","required":true,"description":"Recalling firm."},{"name":"product_description","type":"string","required":true,"description":"Product description."},{"name":"reason_for_recall","type":"string","required":true,"description":"Reason for recall."},{"name":"product_quantity","type":"string","required":true,"description":"Product quantity."},{"name":"distribution_pattern","type":"string","required":true,"description":"Distribution pattern."},{"name":"voluntary_mandated","type":"string","required":true,"description":"Voluntary mandated."},{"name":"country","type":"string","required":true,"description":"Country."},{"name":"state","type":"string","required":true,"description":"State."},{"name":"source_url","type":"string","required":true,"description":"Source url."}],"source":"product_output_contract","field_count":14,"schema_hash":"0d49dcdc9f180d85b3b00575a4b8ebd2fbfac71d96c91d8cdb08e8b717c7f796","record_label":"fda_device_recall_enforcement_record","manifest_path":"zentra\/products\/datasets\/fda-medical-device-recall-enforcement-quarterly-archive\/versions\/2026-Q3.f90d4585599f\/artifacts\/manifest.json","required_fields":["recall_number","report_date","recall_initiation_date","classification","status","recalling_firm","product_description","reason_for_recall","product_quantity","distribution_pattern","voluntary_mandated","country","state","source_url"]},"update_cadence":"Snapshot-driven","freshness_label":"4 hours ago","provenance":[{"label":"Foundry product package","source":"ProductStudio public-safe metadata"}],"quality":{"content_score":100,"requires_owner_review":true,"source":"zentra_products"},"pricing_hint":null,"pricing_events":[],"related_products":[],"related_use_cases":[],"is_bundle":false,"bundle_type":null,"bundle_family":null,"bundle_version":null,"member_count":0,"member_products":[],"bundle_coverage":{"fixed_edition_contract":{"key":"fda_device_recall_enforcement","kind":"public_archive","fields":[{"name":"recall_number","type":"string","required":true,"description":"Recall number."},{"name":"report_date","type":"string","required":true,"description":"Report date."},{"name":"recall_initiation_date","type":"string","required":true,"description":"Recall initiation date."},{"name":"classification","type":"string","required":true,"description":"Classification."},{"name":"status","type":"string","required":true,"description":"Status."},{"name":"recalling_firm","type":"string","required":true,"description":"Recalling firm."},{"name":"product_description","type":"string","required":true,"description":"Product description."},{"name":"reason_for_recall","type":"string","required":true,"description":"Reason for recall."},{"name":"product_quantity","type":"string","required":true,"description":"Product quantity."},{"name":"distribution_pattern","type":"string","required":true,"description":"Distribution pattern."},{"name":"voluntary_mandated","type":"string","required":true,"description":"Voluntary mandated."},{"name":"country","type":"string","required":true,"description":"Country."},{"name":"state","type":"string","required":true,"description":"State."},{"name":"source_url","type":"string","required":true,"description":"Source url."}],"billing":"one_time","pricing":{"mode":"marketplace_native","tiers":[{"name":"FDA Medical Device Recall Enforcement Quarterly Archive fixed edition","amount_usd":34,"deliverable":"One immutable, versioned download with schema, sample, provenance, quality evidence, licence, limitations, and checksums.","billing_type":"one_time"}],"billing":"one_time","currency":"USD","amount_minor":3400,"pricing_basis":"product_specific_buyer_value_and_comparable_self_serve_downloads","evidence_captured_at":"2026-07-16","buyer_value_rationale":"Normalized FDA device-recall enforcement evidence saves recurring compliance research time while remaining an immutable reference archive rather than an alert or advisory service.","recurring_subscription":false,"comparable_evidence_urls":["https:\/\/procurementpro.gumroad.com\/l\/cekmb","https:\/\/yesinyagami.gumroad.com\/l\/mcp-security-checklist","https:\/\/theapexintelligence.gumroad.com\/l\/brkvdxx","https:\/\/ogbonna66.gumroad.com\/l\/GA4GrowthAudittemplate","https:\/\/schueppler.gumroad.com\/l\/kauls","https:\/\/qualitydoc.gumroad.com\/","https:\/\/spdata.gumroad.com\/l\/oblyrb"],"comparable_price_band_usd":{"low":19,"high":49.04}},"immutable":true,"recurring_subscription":false}},"flags":[],"route":"datasets","category":"dataset_snapshot","is_visible":true,"is_x402_eligible":true,"is_x402_ready":true,"content_score":100,"canonical_path":"\/datasets\/fda-medical-device-recall-enforcement-quarterly-archive","api_path":"\/api\/public\/foundry\/products\/fda-medical-device-recall-enforcement-quarterly-archive","seo":{"title":"FDA Medical Device Recall Enforcement Quarterly Archive","description":"Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.","noindex":false},"last_updated_at":"2026-07-21T20:12:27+02:00"}}