FDA daily for Friday, September 18, 2026
In this issue: 35 shortage updates, 17 approvals, 24 device recalls and 26 device decisions. 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.
- Sterile Water Irrigant
Baxter Healthcare · Available
- MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc. · Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Drug shortages
FDA date:FDA updated 35 shortage entries on Thu, Sep 17: 35 status updates.
- Sterile Water Irrigant
Baxter Healthcare · Available
- Lisdexamfetamine Dimesylate Capsule
Mylan Pharmaceuticals Inc., a Viatris Company · Available
- Dextrose Monohydrate 5% Injection
Baxter Healthcare · Available
- Ropivacaine Hydrochloride Injection
Eugia US LLC · Available
- Etomidate Injection
Eugia US LLC · Unavailable · Reason: Demand increase for the drug
- Bupivacaine Hydrochloride Injection
Eugia US LLC · Available
- Rocuronium Bromide Injection
Mylan Institutional, a Viatris Company · Available
- Lidocaine Hydrochloride Injection
Eugia US LLC · Unavailable · Reason: Demand increase for the drug
- Ketorolac Tromethamine Injection
Baxter Healthcare · Unavailable · Reason: Demand increase for the drug
- Lisdexamfetamine Dimesylate Capsule
Alvogen · Available
- Amino Acid Injection
Baxter Healthcare · Available
- Carboplatin Injection
Eugia US LLC · Unavailable · Reason: Demand increase for the drug
- Dexmedetomidine Hydrochloride Injection
Mylan Institutional, a Viatris Company · Available
- Remifentanil Hydrochloride Injection
Mylan Institutional, a Viatris Company · Available
Drug and biologic approvals
FDA date:On Fri, Sep 11 FDA approved 3 new applications (2 brand or biologic, 1 generic) and 14 supplements to existing ones.
- ISEMBYLD
SCHOLAR ROCK INC · APITEGROMAB-MSTN
- DASATINIB
MSN · DASATINIB
- PIXCLARA
TELIX PHARMACEUTICALS US INC · FLORETYROSINE F 18
Device recalls
FDA date:FDA posted 24 device recalls from 9 firms on Fri, Sep 11.
- MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc. · Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; P…
Bard Access Systems, Inc. · this is a downstream recall of class I recall RES 98777
- DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-…
Bard Access Systems, Inc. · this is a downstream recall of class I recall RES 98777
- Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…
Given Imaging Ltd. · Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruct…
- StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Nova Biomedical Corporation · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previou…
- StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Nova Biomedical Corporation · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previou…
- StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Nova Biomedical Corporation · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previou…
- StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Nova Biomedical Corporation · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previou…
- StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Nova Biomedical Corporation · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previou…
- Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Medline Industries, LP · The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be…
- Philips Patient Information Center iX REF:866389
Philips North America · Due to software malfunction, patient information system may freeze and become unresponsive.
- Philips PIC iX Essentials REF:867093
Philips North America · Due to software malfunction, patient information system may freeze and become unresponsive.
Device clearances and approvals
FDA date:FDA decided 17 510(k)s and 9 PMA decisions on Fri, Sep 4.
- NeoPEX Pre-Mixed Obturation Paste
NuSmile, Ltd. · Dental
- TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Sentinel Medical Technologies, · Gastroenterology, Urology
- 70 NeuGlide Catheter
Piraeus Medical, Inc. · Cardiovascular
- Peerbridge COR MDx (Cor MDx)
Peerbridge Health, Inc. · Cardiovascular
- KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O · Orthopedic
- Digital Indeflator INFLANTE
UAB Telemedicina · Cardiovascular
- IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
Siemens Healthcare Diagnostics Products, Ltd. · Immunology
- ATTUNE Revision Knee System
Depuy Orthopaedics, Inc. · Orthopedic
- FCT iStream Phase 2
Fujifilm Corporation · Radiology
- 3D-RD-S
Radiopharmaceutical Imaging & Dosimetry, LLC · Radiology
- Surgical and Prosthetic Trays
Dentsply Sirona, Inc. · General Hospital
- Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · Microbiology
- Gastric Alimetry
Alimetry , Ltd. · Gastroenterology, Urology
- Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Ortho Clinical Diagnostics Inc. (QuidelOrtho) · Microbiology
FDA did not answer for Food and supplement recalls, Drug recalls, Labels while this issue was written; those sections will fill in on a later visit.
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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