FDA daily

FDA daily for Thursday, September 3, 2026

In this issue: 2 shortage updates, 12 approvals, 4 device recalls and 17 device decisions. 2 items touch categories MedGrid carries, and they come first.

For MedGrid's categories

Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.

Drug shortages

FDA date:

FDA updated 2 shortage entries on Wed, Sep 2: 2 status updates.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Thu, Aug 27 FDA approved 4 new applications (3 brand or biologic, 1 generic) and 8 supplements to existing ones.

Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 4 device recalls from 1 firm on Thu, Aug 27.

  • PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209

    GE Medical Systems Information Technologies Inc · Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults fol…

    Open, ClassifiedDevice DesignZ-3036-2026
  • PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592

    GE Medical Systems Information Technologies Inc · Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults fol…

    Open, ClassifiedDevice DesignZ-3037-2026
  • PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

    GE Medical Systems Information Technologies Inc · Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults fol…

    Open, ClassifiedDevice DesignZ-3038-2026
  • FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

    GE Medical Systems Information Technologies Inc · Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults fol…

    Open, ClassifiedDevice DesignZ-3039-2026
Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 10 510(k)s and 7 PMA decisions on Thu, Aug 20, including 1 original PMA.

Browse device clearances and approvals in FDA data →

FDA did not answer for Food and supplement recalls, Drug recalls, Labels while this issue was written; those sections will fill in on a later visit.

How the FDA daily is written

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.