FDA daily for Friday, October 16, 2026
In this issue: 49 shortage updates, 7 approvals, 14 device recalls, 35 device decisions and 2 label changes. 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 Injection
Fresenius Kabi USA, LLC · Available
- Hemostatic Clip
Anrei Medical (Hz) Co., Ltd. · Gastroenterology, Urology
Drug shortages
FDA date:FDA updated 49 shortage entries on Thu, Oct 15: 49 status updates.
- Sterile Water Injection
Fresenius Kabi USA, LLC · Available
- Midazolam Hydrochloride Injection
Fresenius Kabi USA, LLC · Available
- Lidocaine Hydrochloride Injection
Fresenius Kabi USA, LLC · Unavailable · Reason: Demand increase for the drug
- Ropivacaine Hydrochloride Injection
Fresenius Kabi USA, LLC · Available
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Oryza Pharmaceuticals Inc. · Unavailable · Reason: Shortage of an active ingredient
- Bupivacaine Hydrochloride Injection
Fresenius Kabi USA, LLC · Unavailable · Reason: Delay in shipping of the drug
- Atropine Sulfate Injection
Medefil, Inc. · Available
- Lisdexamfetamine Dimesylate Tablet, Chewable
Takeda Pharmaceuticals USA Inc. · Available
- Carboplatin Injection
Teva Pharmaceuticals USA, Inc. · Limited Availability · Reason: Other
- Dexmedetomidine Hydrochloride Injection
Fresenius Kabi USA, LLC · Unavailable · Reason: Delay in shipping of the drug
- Riluzole Oral Suspension
EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) · Available
- Lisdexamfetamine Dimesylate Capsule
Lannett Company, Inc. · Available
- Fentanyl Citrate Injection
Fresenius Kabi USA, LLC · Available
- Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Fresenius Kabi USA, LLC · Unavailable · Reason: Demand increase for the drug
- Hydromorphone Hydrochloride Injection
Fresenius Kabi USA, LLC · Available
Drug and biologic approvals
FDA date:On Fri, Oct 9 FDA approved 2 new applications (2 brand or biologic, 0 generic) and 5 supplements to existing ones.
- ISOVUE READI
BRACCO · IOPAMIDOL
- HOVILPR
AICURIS ANTI-INFECTIVE CURES AG · PRITELIVIR
Device recalls
FDA date:FDA posted 14 device recalls from 10 firms on Fri, Oct 9.
- JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Jenavalve Technology Inc. · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Jenavalve Technology Inc. · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Jenavalve Technology Inc. · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
Medtronic Sofamor Danek USA Inc · Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to…
- Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
Medtronic Sofamor Danek USA Inc · Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to…
- BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Becton Dickinson & Co. · Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Becton Dickinson & Co. · Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The…
Cadwell Industries Inc · Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the…
- NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced T…
Neuronetics, Inc. · Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific Corporation · Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this devi…
- Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Sarnova HC, Llc · Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
- Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium…
Ferno-Washington Inc · Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system…
Device clearances and approvals
FDA date:FDA decided 27 510(k)s and 8 PMA decisions on Fri, Oct 2.
- Hemostatic Clip
Anrei Medical (Hz) Co., Ltd. · Gastroenterology, Urology
- Elecsys EBV VCA IgG
Roche Diagnostics · Microbiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Radiology
- OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
OsteoCentric Technologies · Orthopedic
- TDM Large Bone Plate and Screw System
Tdm Co., Ltd. · Orthopedic
- Elecsys EBV EBNA IgG
Roche Diagnostics · Microbiology
- Xpert Xpress CoV-2/Flu plus
Cepheid® · Microbiology
- REMEX-T(K)100C
Remedi, Inc. · Radiology
- Lung Guidance
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
- Response Ortho Smart Fixator - Hexapod System
Response Ortho Solutions, LLC · Orthopedic
- cCeLL405
VPIX Medical, Inc. · Neurology
- Neurora
Argus Cognitive, Inc. · Neurology
- Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
Shenzhen Ninenovo Technology Limited · Cardiovascular
- Medical Monitor (32MD08WC)
Lg Electronics.Inc · Radiology
Label updates
FDA date:2 drug labels took effect on Fri, Oct 2.
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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