FDA daily for Tuesday, April 14, 2026
In this issue: 7 approvals, 21 device recalls, 9 device decisions and 174 label changes. 4 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.
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medlin…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Badger SPF 30 Face Mineral Sunscreen
ZINC OXIDE · W.S. Badger Company, Inc. · TOPICAL
Drug and biologic approvals
FDA date:On Tue, Apr 7 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 4 supplements to existing ones.
- EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
MACLEODS PHARMS · EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE
- IVERMECTIN
AJANTA PHARMA LTD · IVERMECTIN
- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
PHARMAZONE · NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
Device recalls
FDA date:FDA posted 21 device recalls from 3 firms on Tue, Apr 7.
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medlin…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medlin…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medlin…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…
Device clearances and approvals
FDA date:FDA decided 6 510(k)s and 3 PMA decisions on Tue, Mar 31.
- Nd: YAG Laser Therapy Systems
Sanhe Meditech Co., Ltd. · General, Plastic Surgery
- RW-1
Mediott, Inc. · Radiology
- K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine
- Safety lancet (XXXVII)
Tianjin Huahong Technology Co., Ltd. · General, Plastic Surgery
- Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
VATECH Co., Ltd. · Radiology
- InjecSURE Injection System
Carbon Medical Technologies, Inc. · Gastroenterology, Urology
Label updates
FDA date:174 drug labels took effect on Tue, Mar 31; 4 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Badger SPF 30 Face Mineral Sunscreen
ZINC OXIDE · W.S. Badger Company, Inc. · TOPICAL
- Depakote
DIVALPROEX SODIUM · AbbVie Inc. · ORAL
- Irbesartan
IRBESARTAN · NorthStar RxLLC · ORAL
- Depakote ER
DIVALPROEX SODIUM · AbbVie Inc. · ORAL
- Valproic Acid
VALPROIC ACID · ANI Pharmaceuticals, 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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