FDA daily for Thursday, September 24, 2026
In this issue: 12 approvals, 3 device recalls, 24 device decisions and 75 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.
- Pur Confort SPF 15
AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE · Guinot · TOPICAL
- Hydra Finish SPF 15
HOMOSALATE, OCTINOXATE · Guinot · TOPICAL
Drug and biologic approvals
FDA date:On Thu, Sep 17 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 10 supplements to existing ones.
- CALCIUM GLUCONATE IN SODIUM CHLORIDE
CIPLA · CALCIUM GLUCONATE
- CYCLOSPORINE
AUROBINDO PHARMA LTD · CYCLOSPORINE
Device recalls
FDA date:FDA posted 3 device recalls from 3 firms on Thu, Sep 17.
- Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm…
F & A Foundation · Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-76…
ICU Medical, Inc. · Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under deliver…
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD · Transfemoral catheter, positing arm may detached due to weld issue.
Device clearances and approvals
FDA date:FDA decided 16 510(k)s and 8 PMA decisions on Thu, Sep 10.
- 4K Camera Head OLYMPUS CH-S700-08-LB
Olympus Medical Systems Corp. · Gastroenterology, Urology
- Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology, Inc. · Neurology
- EVOLUTION MPX Total Knee System
Suzhou Microport Orthorecon Co., Ltd. · Orthopedic
- ACUNAV Luxera 4D ICE Catheter
Siemens Medical Solutions USA, Inc. · Cardiovascular
- 4DM
INVIA, LLC · Radiology
- TruPress
Procerus Enterprises · Cardiovascular
- Cerasmart Forte
GC America, Inc. · Dental
- BioTeke® Multi-Drug Urine Test Cup
Bioteke Corporation (Wuxi) Co., Ltd. · Clinical Toxicology
- Diode Laser Therapy System
Sanhe LEFIS Electronics Co., Ltd. · General, Plastic Surgery
- Upper Arm Blood pressure monitor (BP7155D)
OMRON Healthcare, Inc. · Cardiovascular
- Irrigation/Urology Sets
B.Braun Medical, Inc. · Gastroenterology, Urology
- Quicktome Software Suite
Omniscient Neurotechnology Pty, Ltd. · Radiology
- LT Antibacterial Foam with Silver Dressing
Zhejiang Longterm Medical Technology Co., Ltd. · General, Plastic Surgery
- Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
Lakong Medical Devices Co., Ltd. · Dental
- Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
Wuhan Pioon Technology Co., Ltd. · General, Plastic Surgery
Label updates
FDA date:75 drug labels took effect on Thu, Sep 10; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Pur Confort SPF 15
AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE · Guinot · TOPICAL
- Hydra Finish SPF 15
HOMOSALATE, OCTINOXATE · Guinot · TOPICAL
- Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45
AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE · Kenvue Brands LLC · TOPICAL
- Xarelto, XARELTO
RIVAROXABAN · Janssen Pharmaceuticals, Inc. · ORAL
- Glatiramer Acetate
GLATIRAMER ACETATE · AJENAT PHARMACEUTICALS LLC · SUBCUTANEOUS
- Levothyroxine sodium
LEVOTHYROXINE SODIUM · REMEDYREPACK INC. · ORAL
FDA did not answer for Drug shortages, Food and supplement recalls, Drug recalls 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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