FDA daily for Tuesday, September 29, 2026
In this issue: 13 approvals, 4 device recalls, 18 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.
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
DeRoyal Industries Inc · Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Drug and biologic approvals
FDA date:On Tue, Sep 22 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 10 supplements to existing ones.
- AMLODIPINE BESYLATE
IPCA LABS LTD · AMLODIPINE BESYLATE
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
SENORES PHARMS · HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE
- EMPAGLIFLOZIN
INVAGEN PHARMS · EMPAGLIFLOZIN
Device recalls
FDA date:FDA posted 4 device recalls from 3 firms on Tue, Sep 22.
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
DeRoyal Industries Inc · Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
- nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100…
Criticare Technologies, Inc. · Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
- Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, P…
Cardinal Health 200, LLC · The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could…
- Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalo…
Cardinal Health 200, LLC · The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could…
Device clearances and approvals
FDA date:FDA decided 11 510(k)s and 7 PMA decisions on Tue, Sep 15, including 1 original PMA.
- OncoMate® MSI Dx Analysis System
Promega Corporation · Nucleic Acid Based Assay, Microsatellite Instability · Medical Genetics
- Tontarra Punches and Rongeurs
Tontarra Medizintechnik GmbH · Neurology
- CVAC® Aspiration System
Calyxo, Inc. · Gastroenterology, Urology
- Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine
- OOOPDS
Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Radiology
- YJ-K1K2 Wheelchair (YJ-013F)
Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine
- TMC Implant Fixation System
Treace Medical Concepts, Inc. · Orthopedic
- LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Covidien, LLC · General, Plastic Surgery
- SPINEsim v1.0
Mdsim S.A. · Radiology
- Reclining wheelchair (YJ-013L)
Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine
- Artificial Intelligence Renal Assessment (AIRA) Version 1
Aramis Global AI Consultancies, LLC · Radiology
- GMK Extension
Medacta International SA · Orthopedic
Label updates
FDA date:4 drug labels took effect on Tue, Sep 15.
Browse label updates in FDA data →FDA did not answer for Drug recalls, Drug shortages, Food and supplement 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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