FDA daily for Tuesday, August 18, 2026
In this issue: 3 shortage updates, 99 approvals, 4 device recalls, 19 device decisions and 165 label changes.
Drug shortages
FDA date:FDA updated 3 shortage entries on Mon, Aug 17: 3 status updates.
- Dexmedetomidine Hydrochloride Injection
HQ Specialty Pharma · Available
- Dexmedetomidine Hydrochloride Injection
Baxter Healthcare · Unavailable · Reason: Other
- Clonazepam Tablet
Teva Pharmaceuticals USA, Inc. · Limited Availability · Reason: Other
Drug and biologic approvals
FDA date:On Tue, Aug 11 FDA approved 1 new application (0 brand or biologic, 1 generic) and 98 supplements to existing ones.
- VALSARTAN
BOSTAL DRUG · VALSARTAN
Device recalls
FDA date:FDA posted 4 device recalls from 4 firms on Tue, Aug 11.
- Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Baxter Healthcare Corporation · Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open p…
- Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10ML…
Spectra Medical Devices, Llc · Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exp…
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Waldemar Link GmbH & Co. KG (Mfg Site) · The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a pr…
- Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Straumann USA LLC · Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the l…
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 9 PMA decisions on Tue, Aug 4.
- OMNI Ultra Surgical System (1-110)
Sight Sciences, Inc. · General Hospital
- LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
Shenzhen Qianyu Technology Co., Ltd. · General, Plastic Surgery
- RealGUIDE
3DIEMME SRL · Radiology
- Navigator Flex Ureteral Access Sheath Set
Boston Scientific Corporation · Gastroenterology, Urology
- Freedom Partial Knee System
Maxx Orthopedics, Inc. · Orthopedic
- Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC · Radiology
- TRIVANCE Hip Stem
Globus Medical, Inc. · Orthopedic
- Vertex Thrombectomy System
Jupiter Endovascular · Cardiovascular
- LED Light Therapy Masks (PE748, PE749, PE756)
Duplex International Trading Limited · General, Plastic Surgery
- Marrow Marxman
Medimetrix, LLC · Gastroenterology, Urology
Label updates
FDA date:165 drug labels took effect on Tue, Aug 4. Below: those, and labels carrying a boxed warning.
- Metformin Hydrochloride
METFORMIN HYDROCHLORIDE · REMEDYREPACK INC. · ORAL
- Lincomycin
LINCOMYCIN · Micro Labs Limited · INTRAMUSCULAR, INTRAVENOUS
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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