{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0208-2026.jsonld", "@type": "schema:Dataset", "name": "Salem Sump PVC Tubes: Product Code/Product Name: 8888265108\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm)", "description": "FDA recall Z-0208-2026 — Cardinal Health 200, LLC is recalling Salem Sump PVC Tubes: Product Code/Product Name: 8888265108\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm) (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0208-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Salem Sump PVC Tubes: Product Code/Product Name: 8888265108\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm)", "manufacturer": { "@type": "schema:Organization", "name": "Cardinal Health 200, LLC" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0208-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0208-2026: Cardinal Health 200, LLC is recalling Salem Sump PVC Tubes: Product Code/Product Name: 8888265108\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm)", "text": "The FDA logged enforcement record Z-0208-2026: Cardinal Health 200, LLC is voluntarily recalling Salem Sump PVC Tubes: Product Code/Product Name: 8888265108\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140\tSalem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288\tSalem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm) — reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-18. Affected lots/codes: Product Code/Product Name/UDI-DI: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 10884521000766 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 10884521020078 8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 10884521020085 8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 10884521020092 8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 10884521020108 8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 10192253012781 8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 10884521000803 8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 10884521000827 8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 10884521000841 8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm) 10884521000858 All Lots. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0208-2026&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0208-2026&lang=eng" } }, "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0208-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0208-2026 as Class II", "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0208-2026&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0208-2026&lang=eng" } }, "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0208-2026/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-0208-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0208-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Cardinal Health 200, LLC", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-09-18", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Product Code/Product Name/UDI-DI: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 10884521000766 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 10884521020078 8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 10884521020085 8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 10884521020092 8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 10884521020108 8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 10192253012781 8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 10884521000803 8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 10884521000827 8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 10884521000841 8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm) 10884521000858 All Lots", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.", "Status": "recorded" } } ] } ] }