FDA daily for Monday, August 3, 2026
In this issue: 9 approvals, 17 device recalls, 11 device decisions and 145 label changes. 3 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.
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
Hartalega NGC Sdn. Bhd. · General Hospital
- 5%Minoxidil Hair Growth Serum
MINOXIDIL · Guangzhou Binsi Clothing Co.,Ltd. · TOPICAL
- 5%Minoxidil Hair Growth Sprays Serum
MINOXIDIL · Guangzhou Binsi Clothing Co.,Ltd. · TOPICAL
Drug and biologic approvals
FDA date:On Mon, Jul 27 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 6 supplements to existing ones.
- DIAZEPAM
LUPIN · DIAZEPAM
- PRUCALOPRIDE SUCCINATE
ALEMBIC · PRUCALOPRIDE SUCCINATE
- FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
CIPLA · FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE
Device recalls
FDA date:FDA posted 17 device recalls from 3 firms on Mon, Jul 27.
- Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
PHILIPS MEDICAL SYSTEMS · The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occ…
- IQon Spectral CT IQon Spectral CT Upgrades
PHILIPS MEDICAL SYSTEMS · The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occ…
- Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 12…
PHILIPS MEDICAL SYSTEMS · The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occ…
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…
Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…
Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model N…
Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model N…
Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…
- EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…
- EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Windstone Medical Packaging, Inc. · Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine H…
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Si…
Windstone Medical Packaging, Inc. · Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine H…
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray…
Windstone Medical Packaging, Inc. · Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine H…
Device clearances and approvals
FDA date:FDA decided 7 510(k)s and 4 PMA decisions on Mon, Jul 20.
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
Hartalega NGC Sdn. Bhd. · General Hospital
- ENDOSCOPE HOLDER (182214)
Aktormed GmbH · Gastroenterology, Urology
- Hi-D Imaging 4TAVR
Hi-D Imaging AG · Radiology
- Thunderbolt System
Responsive Arthroscopy, Inc. · Orthopedic
- Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips
Taiwan Surgical Corporation · General, Plastic Surgery
- Sleep Apnea Feature (v2.0)
Samsung Electronics Co., Ltd. · Anesthesiology
- BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
MacroLux Medical Technology Co., Ltd. · Gastroenterology, Urology
Label updates
FDA date:145 drug labels took effect on Mon, Jul 20; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- 5%Minoxidil Hair Growth Serum
MINOXIDIL · Guangzhou Binsi Clothing Co.,Ltd. · TOPICAL
- 5%Minoxidil Hair Growth Sprays Serum
MINOXIDIL · Guangzhou Binsi Clothing Co.,Ltd. · TOPICAL
- Ibuprofen
IBUPROFEN · PD-Rx Pharmaceuticals, Inc. · ORAL
- Paroxetine
PAROXETINE HYDROCHLORIDE HEMIHYDRATE · REMEDYREPACK INC. · ORAL
- Trazodone Hydrochloride
TRAZODONE HYDROCHLORIDE · REMEDYREPACK INC. · ORAL
- METADATE CD
METHYLPHENIDATE HYDROCHLORIDE · Lannett Company, LLC · ORAL
- Quetiapine Fumarate
QUETIAPINE FUMARATE · REMEDYREPACK INC. · ORAL
- Losartan Potassium
LOSARTAN POTASSIUM · Zydus Pharmaceuticals USA 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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