FDA daily for Friday, June 5, 2026
In this issue: 1 shortage update, 12 approvals, 25 device recalls, 31 device decisions and 140 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.
- Semaglutide Tablet
Novo Nordisk, Inc.
- BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
Taizhou Huangyan Guanhong Plastic Steel Products Factory · General Hospital
Drug shortages
FDA date:FDA updated 1 shortage entry on Thu, Jun 4: 1 new, 1 to be discontinued.
- Semaglutide Tablet
Novo Nordisk, Inc.
Drug and biologic approvals
FDA date:On Fri, May 29 FDA approved 6 new applications (4 brand or biologic, 2 generic) and 6 supplements to existing ones.
- CYPSEDO
HAISCO · CIPEPOFOL
- EPINEPHRINE
HIKMA · EPINEPHRINE
- ZAYNICH
WOCKHARDT BIO AG · CEFEPIME HYDROCHLORIDE, ZIDEBACTAM
- OXCARBAZEPINE
MSN · OXCARBAZEPINE
- CAVHANZA
CYCLE · NILOTINIB
- XOCOVA
SHIONOGI · ENSITRELVIR
Device recalls
FDA date:FDA posted 25 device recalls from 5 firms on Fri, May 29.
- BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcain…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcain…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) wit…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcain…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcain…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcain…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcain…
Becton Dickinson & Company · This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to qu…
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC · Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may n…
- COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in provid…
Covidien LLC · Due to customer complaint regarding incorrect display box labeling.
Device clearances and approvals
FDA date:FDA decided 22 510(k)s and 9 PMA decisions on Fri, May 22.
- Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
Taizhou Huangyan Guanhong Plastic Steel Products Factory · General Hospital
- Apollo TMS Therapy System;Apollo light TMS Therapy System
Mag & More GmbH · Neurology
- AiSteth®
Ai Health Highway India Pvt., Ltd. · Cardiovascular
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Canon Medical Informatics, Inc. · Radiology
- DePuy ATTUNE Knee System
DePuy Orthopaedics, Inc. · Orthopedic
- InQwire Amplatz Guide Wire
Merit Medical Ireland, Ltd. · Cardiovascular
- C-beam
Pulmera, Inc. · Radiology
- Atmo Gas Capsule System
Atmo Biosciences, Ltd. · Gastroenterology, Urology
- uMR Astra
Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Ion-C Navigation Instruments
SurGenTec, LLC · Neurology
- BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
Vivachek Biotech (Hangzhou) Co., Ltd. · Clinical Toxicology
- ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
Genesee Biomedical, Inc. · General, Plastic Surgery
- da Vinci Firefly Imaging System
Intuitive Surgical · Gastroenterology, Urology
- Zenith Distal Access Long Sheath
Suzhou Zenith Vascular SciTech Limited · Cardiovascular
Label updates
FDA date:140 drug labels took effect on Fri, May 22. Below: those, and labels carrying a boxed warning.
- Etodolac
ETODOLAC · PD-Rx Pharmaceuticals, Inc. · ORAL
- LISINOPRIL
LISINOPRIL · Preferred Pharmaceuticals Inc. · ORAL
- Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN · Bryant Ranch Prepack · ORAL
- Cyltezo
ADALIMUMAB-ADBM · Boehringer Ingelheim Pharmaceuticals, Inc.
- HEPCLUDEX
BULEVIRTIDE · Gilead Sciences, Inc. · SUBCUTANEOUS
- TOFIDENCE
TOCILIZUMAB · Organon LLC · INTRAVENOUS
- Desvenlafaxine
DESVENLAFAXINE · Bryant Ranch Prepack · 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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