FDA daily for Tuesday, December 9, 2025
In this issue: 1 shortage update, 7 approvals, 27 device recalls, 29 device decisions and 220 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.
- Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
Olympus Medical Systems Corporation · Gastroenterology, Urology
- IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
Dongguan Lide Electric Appliance Co., Ltd. · General, Plastic Surgery
Drug shortages
FDA date:FDA updated 1 shortage entry on Mon, Dec 8: 1 new, 1 to be discontinued.
- Ampicillin Sodium Injection
Sandoz Inc.
Drug and biologic approvals
FDA date:On Tue, Dec 2 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 4 supplements to existing ones.
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
SANDOZ · METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
- PROPOFOL
EMERGE BIOSCIENCE · PROPOFOL
- LEVETIRACETAM
KNACK · LEVETIRACETAM
Device recalls
FDA date:FDA posted 27 device recalls from 4 firms on Tue, Dec 2.
- IntelliVue MP2. Product Number: M8102A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP5. Product Number: M8105A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP20. Product Number: M8001A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP30. Product Number: M8002A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP40. Product Number: M8003A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP50. Product Number: M8004A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP60. Product Number: M8005A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP70. Product Number: M8007A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP80. Product Number: M8008A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue MP90. Product Number: M8010A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
- IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Philips North America Llc · Potential issue where the IntelliVue monitors did not alarm.
Device clearances and approvals
FDA date:FDA decided 20 510(k)s and 9 PMA decisions on Tue, Nov 25.
- Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
Olympus Medical Systems Corporation · Gastroenterology, Urology
- IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
Dongguan Lide Electric Appliance Co., Ltd. · General, Plastic Surgery
- FEops HEARTguide Simulation Application
Feops NV · Cardiovascular
- LeafPure-Echo (LM-LPNdA)
Shenzhen Leaflife Technology Co., Ltd. · General, Plastic Surgery
- HALO AP Dx
Indica Labs, LLC · Pathology
- ZSFab Lumbar Interbody System
Zsfab, Inc. · Orthopedic
- Hushd Avera
Good Sleep CO Pte , Ltd. · Dental
- Akura Thrombectomy System
Akura Medical · Cardiovascular
- Eva Scalp Cooling System
Stemtech Medical Devices Private Limited · General, Plastic Surgery
- Spectra Platinum
Uzinmedicare Co., Ltd. · Obstetrics/Gynecology
- enCore Night Guard
Encore Guards · Unknown
- BELLUS-Q
Speclipse, Inc. · General, Plastic Surgery
- NX01 (NX01)
Naox Technologies Sas · Neurology
- Medusa Orthopedics Boa External Fixation System
Medusa Orthopedics, LLC · Orthopedic
- Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
Geistlich Pharma AG · Dental
Label updates
FDA date:220 drug labels took effect on Tue, Nov 25; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- buPropion Hydrochloride XL
BUPROPION HYDROCHLORIDE · Oryza pharmaceuticals Inc. · ORAL
- Estradiol
ESTRADIOL · Alvogen Inc. · VAGINAL
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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