FDA daily for Friday, October 9, 2026
In this issue: 12 approvals, 16 device recalls and 38 device decisions. 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.
- Profoject LOR Syringe
CMT Health PTE., Ltd. · Anesthesiology
Drug and biologic approvals
FDA date:On Fri, Oct 2 FDA approved 1 new application (0 brand or biologic, 1 generic) and 11 supplements to existing ones.
- PERAMPANEL
AUROBINDO PHARMA LTD · PERAMPANEL
Device recalls
FDA date:FDA posted 16 device recalls from 10 firms on Fri, Oct 2.
- Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 208…
Medical Action Industries, Inc. 306 · An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
- VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
Steris Corporation · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization…
- VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Steris Corporation · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization…
- VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Steris Corporation · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization…
- VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Steris Corporation · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization…
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Steris Corporation · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization…
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Steris Corporation · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization…
- Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400…
QUANTUM OPS Inc · Due to a manufacturing issue (inadequate weld) for patient head positioning system.
- HALYARD Laparoscopy Comprehensive Pack II REF: 49332
GRI Medical & Electronic Technology Co., Ltd. · Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
- Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (…
PHILIPS MEDICAL SYSTEMS · Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended…
- Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Int…
Cardinal Health 200, LLC · Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the…
- Glypto Device, Glypto Cryo Machine;
Limitless Cryo Spa LLC · Lack of 510(k) clearance.
Device clearances and approvals
FDA date:FDA decided 21 510(k)s and 17 PMA decisions on Fri, Sep 25, including 1 original PMA.
- Liverty TIPS Stent Graft
Bard Peripheral Vascular, Inc. · SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS · Cardiovascular
- Profoject LOR Syringe
CMT Health PTE., Ltd. · Anesthesiology
- Profoject Safety Sliding Blood Collection Set
CMT Health PTE., Ltd. · Clinical Chemistry
- easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges
Ezisurg Medical Co., Ltd. · General, Plastic Surgery
- DistaSense(TM) (v1)
Life Detection Technologies · Cardiovascular
- CapsoView (CVV); CapsoCloud (CLD)
CapsoVision, Inc. · Gastroenterology, Urology
- EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC · Radiology
- Tempus ECG-MR
Tempus AI, Inc. · Cardiovascular
- Invisalign System
Align Technology, Inc. · Dental
- S-Patch CardioAI
Wellysis Corp. · Cardiovascular
- Aevice Wheeze Detection Module
Aevice Health Pte. , Ltd. · Anesthesiology
- TumorSight Risk
SimBioSys, Inc. · Pathology
- Braun Aura 9 (6042)
Cyden Limited · General, Plastic Surgery
- syngo.CT Brain Quantification
Siemens Medical Solutions USA, Inc. · Radiology
- 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
Solventum US, LLC · General Hospital
FDA did not answer for Labels, Food and supplement recalls, Drug shortages, 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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