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  "name": "Basic Biopsy Tray, Item Number NMBP44L",
  "description": "FDA recall Z-0170-2026 — American Contract Systems Inc. is recalling Basic Biopsy Tray, Item Number NMBP44L (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.",
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      "name": "FDA recall Z-0170-2026: American Contract Systems Inc. is recalling Basic Biopsy Tray, Item Number NMBP44L",
      "text": "The FDA logged enforcement record Z-0170-2026: American Contract Systems Inc. is voluntarily recalling Basic Biopsy Tray, Item Number NMBP44L — reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-04. Affected lots/codes: UDI-DI 191072188120 Lot 8515411 Entire lot impacted. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0170-2026 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.",
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      "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.",
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      "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."
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