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  "name": "AcoSound. Model Number: LW12-BTE-M",
  "description": "FDA recall Z-1976-2025 — HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. is recalling AcoSound. Model Number: LW12-BTE-M (Devices, Class III). 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-1976-2025: HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. is recalling AcoSound. Model Number: LW12-BTE-M",
      "text": "The FDA logged enforcement record Z-1976-2025: HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. is voluntarily recalling AcoSound. Model Number: LW12-BTE-M — reason: Three issues   1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as \"Developed by AcoSound,\" Correct should be \"Manufactured by Hangzhou AcoSound.\" And the labeling has no statement of the place of business for the manufacturer.  2. Customer information: The customer \"Blaid\" information is not correctly marked; Blaid is not the manufacturer.  3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-25. Affected lots/codes: UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1976-2025 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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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      "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.",
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