FDA daily for Thursday, August 20, 2026
In this issue: 6 approvals, 9 device recalls, 18 device decisions and 181 label changes. 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.
- ZENBEXUS
BRISTOL MYERS SQUIBB · IBERDOMIDE HYDROCHLORIDE
- EltaMD UV Restore
TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN · CP Skin Health Group, Inc · TOPICAL
Drug and biologic approvals
FDA date:On Thu, Aug 13 FDA approved 3 new applications (2 brand or biologic, 1 generic) and 3 supplements to existing ones.
- ZENBEXUS
BRISTOL MYERS SQUIBB · IBERDOMIDE HYDROCHLORIDE
- FIDAXOMICIN
SANDOZ · FIDAXOMICIN
- TAUKLARIFY
CERVEAU LANTHEUS · FLORQUINITAU F-18
Device recalls
FDA date:FDA posted 9 device recalls from 2 firms on Thu, Aug 13.
- 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI c…
BD SWITZERLAND SARL · Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in produ…
- Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,B…
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Nu…
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNO…
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: C…
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3)…
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
- Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Cat…
Cardinal Health 200, LLC · Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to une…
Device clearances and approvals
FDA date:FDA decided 9 510(k)s and 9 PMA decisions on Thu, Aug 6.
- Aristotle Mini Guidewire
Scientia Vascular, Inc. · Cardiovascular
- Overjet Multi-Image Caries and Charting Assist
Overjet, Inc. · Radiology
- QIAstat-Dx BCID GPF Plus AMR Panel
QIAGEN GmbH · Microbiology
- Manual Wheelchair (H008, PCK7)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Physical Medicine
- Megalodon Dynamic Compression System
Paragon 28, Inc. · Orthopedic
- Telemetry Monitor (iT30, iT50)
Edan Instruments, Inc. · Cardiovascular
- Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
Howmedica Osteonics Corp. dba Stryker Orthopaedics · Orthopedic
Label updates
FDA date:181 drug labels took effect on Thu, Aug 6; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- EltaMD UV Restore
TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN · CP Skin Health Group, Inc · TOPICAL
- Quetiapine
QUETIAPINE · Ascend Laboratories, LLC · ORAL
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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