The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027. The FDA said the shortage is due to a manufacturing disruption and that clinical management adjustments may be required for patients needing a breast biopsy. Healthcare providers are recommended to conserve their use of stereotactic breast biopsy needles. The agency said that Hologic issued a customer letter Jan. 2 that said all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk of metal and plastic particles being dislodged from the device during use. 

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The Administration for Strategic Preparedness and Response announced Nov. 3 that it will partner with the Bureau of Industry and Security and the Assistant…
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The Food and Drug Administration has identified Class I recalls of two products: certain platelet factor 4 radioimmunoassay products by Instrumentation…
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The Food and Drug Administration released draft guidance Sept. 24 that includes recommendations on non-clinical testing, clinical data and labeling for…
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The Department of Health and Human Services Sept. 18 announced the launch of a new personal protective equipment forecast to identify, consolidate and publish…
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The Food and Drug Administration has identified Class I recalls of the following products: Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits and…
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The Food and Drug Administration has identified a Class I recall of certain convenience kits by AVID Medical that contain recalled Medline Namic Angiographic…