FDA daily for Thursday, October 1, 2026
In this issue: 6 shortage updates, 17 approvals, 8 device recalls, 27 device decisions and 10 label changes.
Drug shortages
FDA date:FDA updated 6 shortage entries on Wed, Sep 30: 5 resolved, 1 status update.
- Bumetanide Injection
Mullan Pharmaceutical Inc.
- Cromolyn Sodium Concentrate
Ailex Pharmaceuticals · Available
- Bumetanide Injection
MSN Laboratories Private Limited
- Bumetanide Injection
Hikma Pharmaceuticals USA, Inc.
- Bumetanide Injection
Sagent Pharmaceuticals
- Bumetanide Injection
Fresenius Kabi USA, LLC
Drug and biologic approvals
FDA date:On Thu, Sep 24 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 14 supplements to existing ones.
- PHENYLEPHRINE HYDROCHLORIDE
NEPHRON · PHENYLEPHRINE HYDROCHLORIDE
- CRISABOROLE
MACLEODS PHARMS · CRISABOROLE
- LINACLOTIDE
ACTAVIS LABS FL · LINACLOTIDE
Device recalls
FDA date:FDA posted 8 device recalls from 2 firms on Thu, Sep 24.
- PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves…
Baxter Healthcare Corporation · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pr…
- PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…
Baxter Healthcare Corporation · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pr…
- PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…
Baxter Healthcare Corporation · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pr…
- Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Cata…
Medline Industries, LP · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present heal…
- Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Medline Industries, LP · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present heal…
- Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) S…
Medline Industries, LP · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present heal…
- Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK…
Medline Industries, LP · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present heal…
- Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3)…
Medline Industries, LP · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present heal…
Device clearances and approvals
FDA date:FDA decided 18 510(k)s and 9 PMA decisions on Thu, Sep 17.
- Miru 1day UpSide (midafilcon A)
Menicon Co, Ltd. · Ophthalmic
- Wearable Breast Pump (Model S36)
Shenzhen TPH Technology Co., Ltd. · Obstetrics/Gynecology
- TriActive Dental Implant System
Paragon Implant Mfg., LLC · Dental
- Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd. · General, Plastic Surgery
- The VEGA Cervical Screw System
GS Medical Co., Ltd. · Orthopedic
- LED Therapy Device (QLXY-01)
Beijing Nubway S&T Co., Ltd. · General, Plastic Surgery
- MOWANA Auto Duo
PENTAMASTER MEDIQ SDN BHD · General Hospital
- Protégé EverFlex Self-expanding Peripheral Stent System
Medtronic, Inc. · Gastroenterology, Urology
- Vessel Closure Device (VCD177213P)
Vcd Medical S.R.L. · General, Plastic Surgery
- FRAXION Spinal Fixation System
Ortler Global Tibbi Gerecler Anonim Sirketi · Orthopedic
- EnSite X EP System
Abbott Medical · Cardiovascular
- M-Vizion Femoral Revision System Extension
Medacta International S.A. · Orthopedic
- Durashield Device Kit
SurGenTec, LLC · Neurology
- HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
Ethicon Endo-Surgery, LLC · General, Plastic Surgery
Label updates
FDA date:10 drug labels took effect on Thu, Sep 17.
Browse label updates in FDA data →FDA did not answer for Food and supplement recalls, Drug recalls 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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