FDA daily for Tuesday, February 24, 2026
In this issue: 18 approvals, 57 device recalls, 39 device decisions and 135 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.
- Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERA…
Medline Industries, LP · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ste…
Drug and biologic approvals
FDA date:On Tue, Feb 17 FDA approved 5 new applications (1 brand or biologic, 4 generic) and 13 supplements to existing ones.
- SODIUM PHENYLBUTYRATE
NAVINTA LLC · SODIUM PHENYLBUTYRATE
- COLCHICINE
MICRO LABS · COLCHICINE
- MEDICAL AIR, USP
INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC
- BOSENTAN
ZYDUS PHARMS · BOSENTAN
- IDELALISIB
NATCO · IDELALISIB
Device recalls
FDA date:FDA posted 57 device recalls from 5 firms on Tue, Feb 17.
- Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERA…
Medline Industries, LP · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ste…
- Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
- Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Olympus Corporation of the Americas · Firm is initiating a removal due to continued reports of adverse events.
Device clearances and approvals
FDA date:FDA decided 11 510(k)s and 28 PMA decisions on Tue, Feb 10, including 1 original PMA.
- Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
Contamac, Ltd. · Lens, contact, orthokeratology, overnight · Ophthalmic
- Solidex® Ti-Links and Screws
CreoDent Hudson Valley · Dental
- CollOvine Wound Powder
Ovigenex, LLC · Unknown
- SpaceOAR Vue System (SV-2101)
Boston Scientific Corporation · Radiology
- Earflo (EF001)
Earflo, Inc. · Unknown
- XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
Biodynamik, Inc. · Orthopedic
- MI View&GO
Siemens Medical Solutions USA, Inc. · Radiology
- LANDR Contact LENS Case
Fourth Axis, LLC · Ophthalmic
- multiFlux 130 (F00013123); multiFlux 160 (F00013124)
Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology, Urology
- GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
Shenzhen RF Tech Co., Ltd. · Radiology
- Vulcan Spinal System
K2m, Inc. · Orthopedic
Label updates
FDA date:135 drug labels took effect on Tue, Feb 10; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
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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