FDA daily for Monday, August 17, 2026
In this issue: 9 approvals, 6 device recalls, 11 device decisions and 125 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.
- Sildenafil
SILDENAFIL · Jubilant Cadista Pharmaceuticals Inc. · ORAL
Drug and biologic approvals
FDA date:On Mon, Aug 10 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 7 supplements to existing ones.
- BRIVARACETAM
AUROBINDO PHARMA · BRIVARACETAM
- GADOTERATE MEGLUMINE
VIWIT PHARM · GADOTERATE MEGLUMINE
Device recalls
FDA date:FDA posted 6 device recalls from 4 firms on Mon, Aug 10.
- Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Firmware issue potentially leading to loss of geometry movements.
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Straumann USA LLC · There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implan…
- GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a c…
Terumo Medical Corporation · Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complicatio…
- Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedur…
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
OBP Medical Corporation · There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both th…
Device clearances and approvals
FDA date:FDA decided 8 510(k)s and 3 PMA decisions on Mon, Aug 3.
- Halcyon, Ethos Radiotherapy System (5.0)
Varian Medical Systems, Inc. · Radiology
- VueJect® Ultrasound Enhancing Agent Delivery System
ACIST Medical Systems, Inc. · Cardiovascular
- XLITE
GEMSS HEALTHCARE CO., LTD. · Radiology
- PuraStat-RM
3-D Matrix, Inc. · Unknown
- PuraStat GI
3-D Matrix, Inc. · General, Plastic Surgery
- Eve
Wandercraft SAS · Physical Medicine
- SABER-XA System
Elevation Spine · Orthopedic
- Grappler Suture Anchor System
Paragon 28, Inc. · Orthopedic
Label updates
FDA date:125 drug labels took effect on Mon, Aug 3; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Sildenafil
SILDENAFIL · Jubilant Cadista Pharmaceuticals Inc. · ORAL
- Metformin Hydrochloride
METFORMIN HYDROCHLORIDE · PD-Rx Pharmaceuticals, Inc. · ORAL
- Naproxen
NAPROXEN · PD-Rx Pharmaceuticals, Inc. · 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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