FDA daily for Tuesday, June 23, 2026
In this issue: 8 approvals, 6 device recalls, 16 device decisions and 155 label changes. 1 item touches categories MedGrid carries, and it comes 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.
- Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Hathor Professional Skincare , Ltd. · Obstetrics/Gynecology
Drug and biologic approvals
FDA date:On Tue, Jun 16 FDA approved 2 new applications (1 brand or biologic, 1 generic) and 6 supplements to existing ones.
- APREPITANT
AZURITY · APREPITANT
- ATOMOXETINE HYDROCHLORIDE
PHARMAZONE · ATOMOXETINE HYDROCHLORIDE
Device recalls
FDA date:FDA posted 6 device recalls from 4 firms on Tue, Jun 16.
- Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Elev…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended r…
- Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 7…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended r…
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Smith & Nephew, Inc. · Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before…
- Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C;…
AMD Medicom Inc. · Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not…
- Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
AMD Medicom Inc. · Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not…
- directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Accriva Diagnostics, Inc. · Assayed Whole blood control contains labeling with incorrect performance range.
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 6 PMA decisions on Tue, Jun 9.
- Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Hathor Professional Skincare , Ltd. · Obstetrics/Gynecology
- LAP-iX2N
Sejong Medical Co., Ltd. · General, Plastic Surgery
- ES-Series
E-Scopics · Radiology
- Mother's Nature W1 Warming Wearable Breast Pump
Shenzhen TPH Technology Co., Ltd. · Obstetrics/Gynecology
- BOBBY Balloon Guide Catheter
MicroVention, Inc., d/b/a Terumo Neuro · Cardiovascular
- TekBrace Solo Soft Tissue Reinforcement Device
Theramicro · General, Plastic Surgery
- ERBECRYO 2 Cryosurgical Unit and Accessories
Erbe Elektromedizin GmbH · General, Plastic Surgery
- ChanPin Pedicle Screw Spinal System
Chanpin Medtak Co., Ltd. · Orthopedic
- Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Materialise NV · Orthopedic
- DESS Dental Smart Solutions
Terrats Medical SL · Dental
Label updates
FDA date:155 drug labels took effect on Tue, Jun 9. Below: those, and labels carrying a boxed warning.
- Progesterone
PROGESTERONE · Bryant Ranch Prepack · ORAL
- Irbesartan
IRBESARTAN · Bryant Ranch Prepack · ORAL
- Nabumetone
NABUMETONE · REMEDYREPACK 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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