FDA daily for Monday, September 28, 2026
In this issue: 1 approval, 2 device recalls and 2 label changes.
Drug and biologic approvals
FDA date:On Mon, Sep 21 FDA approved no new applications and 1 supplement to existing ones.
- WINREVAIR
MERCK SHARP DOHME · SOTATERCEPT-CSRK
Device recalls
FDA date:FDA posted 2 device recalls from 2 firms on Mon, Sep 21.
- ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for us…
Becton, Dickinson and Company · Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA…
Abiomed, Inc. · Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accura…
Label updates
FDA date:2 drug labels took effect on Mon, Sep 14. Below: those, and labels carrying a boxed warning.
- captopril
CAPTOPRIL · AMICI PHARMA, INC. · ORAL
FDA did not answer for Food and supplement recalls, Drug shortages, Drug recalls, Clearances 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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