FDA daily for Friday, September 25, 2026
In this issue: 8 approvals, 35 device recalls, 42 device decisions and 4 label changes. 1 item touches categories MedGrid carries, and it comes 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.
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux Inc · The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe,…
Drug and biologic approvals
FDA date:On Fri, Sep 18 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 5 supplements to existing ones.
- LANREOTIDE ACETATE
AMNEAL · LANREOTIDE ACETATE
- DEFLAZACORT
HIKMA · DEFLAZACORT
- ROCURONIUM BROMIDE
BAXTER HLTHCARE CORP · ROCURONIUM BROMIDE
Device recalls
FDA date:FDA posted 35 device recalls from 13 firms on Fri, Sep 18.
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux Inc · The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe,…
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-…
CooperSurgical, Inc. · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pr…
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712…
CooperSurgical, Inc. · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pr…
- Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimod…
Heidelberg Engineering GmbH · Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a re…
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Olympus Corporation of the Americas · Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
- Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
Midmark Corporation · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
Midmark Corporation · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
Midmark Corporation · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
Midmark Corporation · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Ventec Life Systems, Inc. · Labeling; Oxygen Cylinders do not contain required medical gas labeling
- REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Ventec Life Systems, Inc. · Labeling; Oxygen Cylinders do not contain required medical gas labeling
- REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Ventec Life Systems, Inc. · Labeling; Oxygen Cylinders do not contain required medical gas labeling
Device clearances and approvals
FDA date:FDA decided 29 510(k)s and 13 PMA decisions on Fri, Sep 11.
- Potenza Prime
Jeisys Medical Incorporated · General, Plastic Surgery
- CraniUS Plate
CraniUS, LLC · Neurology
- Single Use Ureteral Access Sheath
Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology, Urology
- GSPE Spacer
The General Hospital Corporation, d/b/a Massachusetts · Orthopedic
- Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System
INNO Holdings Inc. DBA Innovasis · Orthopedic
- CuratOR EX2742
Eizo Corporation · Gastroenterology, Urology
- SpaceOAR Flex System
Boston Scientific Corporation · Radiology
- iLet Dosing Decision Software
Beta Bionics, Inc. · Clinical Chemistry
- MICSI-PET
Microstructure Imaging, Inc. · Radiology
- DRIM-Nail System
41Medical AG · Unknown
- Extroducer Infusion Catheter System
SmartWise Sweden AB · Cardiovascular
- ANTERION
Heidelberg Engineering GmbH · Ophthalmic
- Mint ACE Pump
Beta Bionics, Inc. · Clinical Chemistry
- Ecomed Disposable Administration Sets
Ecomed Solutions, LLC · General Hospital
- RENASYS DYNAFLOW Kit (66807741)
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
Label updates
FDA date:4 drug labels took effect on Fri, Sep 11.
Browse label updates in FDA data →FDA did not answer for Drug recalls, Food and supplement recalls, Drug shortages 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.
Subscribe with any feed reader, or point an email tool at the RSS feed to send each issue as a newsletter. Search any drug, device or company across every FDA dataset in the FDA data explorer.
